Trial Outcomes & Findings for Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001) (NCT NCT00610649)

Last Updated: 2018-11-06

Results Overview

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Up to 7 days following the last dose of study drug (Up to 23 days)

Results posted on

2018-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: Block A MK-8777 Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.	Part 2: MK-8777 200 mg Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.	Part 2: MK-8777 800 mg Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: Placebo Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
Overall Study STARTED	4	2	4	2	4	2	4	2	10	10	10
Overall Study COMPLETED	3	1	4	2	4	2	4	2	10	9	9
Overall Study NOT COMPLETED	1	1	0	0	0	0	0	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Block A MK-8777 Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo Participants receive placebo BID for a total of 16 days.	Part 2: MK-8777 800 mg Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: Placebo Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
Overall Study Adverse Event	1	0	0	1
Overall Study Family Emergency	0	1	0	0
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Block A MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 Participants Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 Participants Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 2: MK-8777 200 mg n=10 Participants Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: MK-8777 800 mg n=10 Participants Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: Placebo n=10 Participants Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.	Total n=54 Participants Total of all reporting groups
Age, Continuous	28.8 years STANDARD_DEVIATION 5.0 • n=99 Participants	32.5 years STANDARD_DEVIATION 13.4 • n=107 Participants	42.0 years STANDARD_DEVIATION 14.8 • n=206 Participants	28.5 years STANDARD_DEVIATION 9.2 • n=7 Participants	35.5 years STANDARD_DEVIATION 9.7 • n=31 Participants	39.0 years STANDARD_DEVIATION 14.1 • n=30 Participants	40.5 years STANDARD_DEVIATION 6.8 • n=3 Participants	36.5 years STANDARD_DEVIATION 23.3 • n=6 Participants	38.3 years STANDARD_DEVIATION 14.4 • n=114 Participants	35.6 years STANDARD_DEVIATION 12.8	31.1 years STANDARD_DEVIATION 6.5 • n=19 Participants	35.4 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	4 Participants n=114 Participants	4 Participants	5 Participants n=19 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	4 Participants n=3 Participants	2 Participants n=6 Participants	6 Participants n=114 Participants	6 Participants	5 Participants n=19 Participants	34 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 7 days following the last dose of study drug (Up to 23 days)

Population: The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 Participants Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 Participants Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.
Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)	2 participants	0 participants	1 participants	2 participants	4 participants	0 participants	3 participants	2 participants

PRIMARY outcome

Timeframe: Up to 30 days following the last dose of study drug (Up to 46 days)

Population: The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 Participants Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 Participants Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.
Part 1: Number of Participants With Serious Adverse Events (SAEs)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to the last dose of study drug (Up to 16 days)

Population: The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 Participants Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 Participants Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.
Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to 7 days following the last dose of study drug (Up to 35 days)

Population: The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=10 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=10 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=10 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.
Part 2: Number of Participants With AEs	10 participants	9 participants	9 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to the last dose of study drug (Up to 28 days)

Population: The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=10 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=10 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=10 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.
Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug	0 participants	0 participants	1 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and end of treatment (Up to Day 16)

Population: The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).

The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 Participants Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 Participants Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 Participants Participants receive placebo BID for a total of 13 days.
Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)	-10.00 score on a scale Standard Deviation 7.53	-24.50 score on a scale Standard Deviation 2.12	-13.50 score on a scale Standard Deviation 14.46	-7.00 score on a scale Standard Deviation 8.49	-10.25 score on a scale Standard Deviation 9.36	-9.50 score on a scale Standard Deviation 3.54	-19.00 score on a scale Standard Deviation 9.76	-2.00 score on a scale Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline and end of treatment (Up to Day 28)

Population: The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).

Outcome measures

Outcome measures
Measure	Part 1: Block A MK-8777 n=10 Participants Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=10 Participants Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=10 Participants Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo Participants receive placebo BID for a total of 13 days.
Part 2: Change From Baseline in the MADRS	-15.40 score on a scale Standard Deviation 6.40	-13.70 score on a scale Standard Deviation 11.57	-13.30 score on a scale Standard Deviation 9.04	—	—	—	—	—

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1: Block A MK-8777 n=4 participants at risk Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.	Part 1: Block A Placebo n=2 participants at risk Participants receive placebo BID for a total of 16 days.	Part 1: Block B MK-8777 n=4 participants at risk Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.	Part 1: Block B Placebo n=2 participants at risk Participants receive placebo BID for a total of 13 days.	Part 1: Block C MK-8777 n=4 participants at risk Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.	Part 1: Block C Placebo n=2 participants at risk Participants receive placebo BID for a total of 10 days.	Part 1: Block D MK-8777 n=4 participants at risk Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.	Part 1: Block D Placebo n=2 participants at risk Participants receive placebo BID for a total of 13 days.	Part 2: MK-8777 200 mg n=10 participants at risk Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: MK-8777 800 mg n=10 participants at risk Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.	Part 2: Placebo n=10 participants at risk Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
Psychiatric disorders Euphoric mood	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Insomnia	75.0% 3/4 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	30.0% 3/10 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Panic attack	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Cardiac disorders Palpitations	50.0% 2/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Congenital, familial and genetic disorders Colour blindness	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Ear and labyrinth disorders Hypoacusis	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Ear and labyrinth disorders Vertigo	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Eye disorders Altered visual depth perception	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Eye disorders Blepharospasm	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Eye disorders Photophobia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Abdominal tenderness	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Constipation	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Gastritis	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	100.0% 4/4 • Number of events 14 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	30.0% 3/10 • Number of events 7 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	30.0% 3/10 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Reflux gastritis	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Chest discomfort	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Fatigue	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	30.0% 3/10 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Feeling abnormal	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Feeling drunk	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	40.0% 4/10 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Irritability	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Non-cardiac chest pain	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
General disorders Temperature intolerance	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Infections and infestations Injection site cellulitis	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Infections and infestations Rhinitis	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Infections and infestations Viral infection	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Injury, poisoning and procedural complications Post lumbar puncture syndrome	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	75.0% 3/4 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	100.0% 2/2 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Musculoskeletal and connective tissue disorders Muscle twitching	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Musculoskeletal and connective tissue disorders Neck pain	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Akathisia	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Bradykinesia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Disturbance in attention	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	75.0% 3/4 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 5/10 • Number of events 7 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Dizziness postural	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Headache	50.0% 2/4 • Number of events 5 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	100.0% 4/4 • Number of events 7 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	75.0% 3/4 • Number of events 9 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	100.0% 2/2 • Number of events 5 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 5/10 • Number of events 8 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	40.0% 4/10 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 5/10 • Number of events 8 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Paraesthesia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Sedation	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Sensory disturbance	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Sinus headache	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Somnolence	75.0% 3/4 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	100.0% 2/2 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	75.0% 3/4 • Number of events 3 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	40.0% 4/10 • Number of events 4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 5/10 • Number of events 5 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 5/10 • Number of events 5 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Syncope	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Tension headache	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Nervous system disorders Tremor	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Abnormal dreams	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Anxiety	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 2/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Bradyphrenia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Depersonalisation	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Phonophobia	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Restlessness	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	25.0% 1/4 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Psychiatric disorders Tension	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	50.0% 1/2 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	10.0% 1/10 • Number of events 1 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	20.0% 2/10 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).
Vascular disorders Hot flush	25.0% 1/4 • Number of events 2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/4 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/2 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).	0.00% 0/10 • Up to 30 days after last dose of study drug for serious AEs (up to 46 days for Part 1; up to 58 days for Part 2). Up to 7 days after last dose of study drug for non-serious AEs (up to 23 days for Part 1; up to 35 days for Part 2).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60