MedTrace Logo

Trial Outcomes & Findings for A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers (NCT NCT02074553)

NCT ID: NCT02074553

Last Updated: 2023-12-11

Results Overview

AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

97 participants

Primary outcome timeframe

Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Results posted on

2023-12-11

Participant Flow

Participant milestones

Participant milestones
Measure
Part 1 (Fasted): Treatment A Then B Then C Then D
Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent \[%\]sodium lauryl sulfate \[SLS\]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment B Then D Then A Then C
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment C Then A Then D Then B
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment D Then C Then B Then A
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment A Then B Then C Then D
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment B Then D Then A Then C
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment C Then A Then D Then B
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment D Then C Then B Then A
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Intervention Period 1
STARTED
12
12
12
13
12
12
12
12
Intervention Period 1
COMPLETED
12
12
12
12
12
12
12
12
Intervention Period 1
NOT COMPLETED
0
0
0
1
0
0
0
0
Washout Period 1
STARTED
12
12
12
12
12
12
12
12
Washout Period 1
COMPLETED
11
12
12
11
12
11
12
12
Washout Period 1
NOT COMPLETED
1
0
0
1
0
1
0
0
Intervention Period 2
STARTED
11
12
12
11
12
11
12
12
Intervention Period 2
COMPLETED
11
12
12
11
12
11
12
12
Intervention Period 2
NOT COMPLETED
0
0
0
0
0
0
0
0
Washout Period 2
STARTED
11
12
12
11
12
11
12
12
Washout Period 2
COMPLETED
11
12
11
11
12
10
11
12
Washout Period 2
NOT COMPLETED
0
0
1
0
0
1
1
0
Intervention Period 3
STARTED
11
12
11
11
12
10
11
12
Intervention Period 3
COMPLETED
11
12
11
11
12
10
11
12
Intervention Period 3
NOT COMPLETED
0
0
0
0
0
0
0
0
Washout Period 3
STARTED
11
12
11
11
12
10
11
12
Washout Period 3
COMPLETED
11
12
11
11
12
10
11
11
Washout Period 3
NOT COMPLETED
0
0
0
0
0
0
0
1
Intervention Period 4
STARTED
11
12
11
11
12
10
11
11
Intervention Period 4
COMPLETED
11
12
11
11
12
10
11
11
Intervention Period 4
NOT COMPLETED
0
0
0
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1 (Fasted): Treatment A Then B Then C Then D
Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent \[%\]sodium lauryl sulfate \[SLS\]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment B Then D Then A Then C
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment C Then A Then D Then B
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 1 (Fasted): Treatment D Then C Then B Then A
Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment A Then B Then C Then D
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment B Then D Then A Then C
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment C Then A Then D Then B
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Part 2 (Fed): Treatment D Then C Then B Then A
Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
Intervention Period 1
Family Emergency
0
0
0
1
0
0
0
0
Washout Period 1
Adverse Event
1
0
0
0
0
0
0
0
Washout Period 1
Physician Decision
0
0
0
1
0
0
0
0
Washout Period 1
Other
0
0
0
0
0
1
0
0
Washout Period 2
Adverse Event
0
0
0
0
0
0
1
0
Washout Period 2
Physician Decision
0
0
0
0
0
1
0
0
Washout Period 2
Lost to Follow-up
0
0
1
0
0
0
0
0
Washout Period 3
Physician Decision
0
0
0
0
0
0
0
1

Baseline Characteristics

A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1 (Fasted): Study Population
n=49 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
Part 2 (Fed): Study Population
n=48 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
Total
n=97 Participants
Total of all reporting groups
Age, Continuous
37.6 years
STANDARD_DEVIATION 10.01 • n=99 Participants
36.1 years
STANDARD_DEVIATION 10.49 • n=107 Participants
36.9 years
STANDARD_DEVIATION 10.2 • n=206 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
6 Participants
n=107 Participants
14 Participants
n=206 Participants
Sex: Female, Male
Male
41 Participants
n=99 Participants
42 Participants
n=107 Participants
83 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: The Pharmacokinetic (PK) analysis set included all participants who received the reference formulation 50% SLS alectinib (Treatment A) and at least 1 test formulation (Treatments B, C, or D) and provided adequate PK assessments.

AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib
1630 ng*hour/mL
Standard Deviation 792
5720 ng*hour/mL
Standard Deviation 1530
5050 ng*hour/mL
Standard Deviation 1200
4600 ng*hour/mL
Standard Deviation 1260
1920 ng*hour/mL
Standard Deviation 1000
1840 ng*hour/mL
Standard Deviation 754
1850 ng*hour/mL
Standard Deviation 841
4580 ng*hour/mL
Standard Deviation 1240

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng\*hour/mL.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib
1380 ng*hour/mL
Standard Deviation 573
5540 ng*hour/mL
Standard Deviation 1460
4820 ng*hour/mL
Standard Deviation 1130
4370 ng*hour/mL
Standard Deviation 1170
1790 ng*hour/mL
Standard Deviation 925
1680 ng*hour/mL
Standard Deviation 620
1620 ng*hour/mL
Standard Deviation 637
4360 ng*hour/mL
Standard Deviation 1160

PRIMARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Maximum Observed Plasma Concentration (Cmax) of Alectinib
42.2 ng/mL
Standard Deviation 19.2
271 ng/mL
Standard Deviation 81.8
232 ng/mL
Standard Deviation 59.3
206 ng/mL
Standard Deviation 50.4
106 ng/mL
Standard Deviation 53.3
91.7 ng/mL
Standard Deviation 34.5
67.0 ng/mL
Standard Deviation 23.6
204 ng/mL
Standard Deviation 57.1

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Tmax is the time from alectinib administration to reach Cmax for alectinib.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib
4.00 hours
Interval 2.5 to 10.0
8.00 hours
Interval 4.05 to 18.0
8.00 hours
Interval 5.0 to 18.0
6.00 hours
Interval 4.0 to 12.0
3.25 hours
Interval 1.5 to 12.0
3.00 hours
Interval 1.0 to 5.0
3.00 hours
Interval 2.0 to 6.0
6.00 hours
Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Cmax is the maximum observed plasma RO5468924 concentration, presented in ng/mL. RO5468924 is the major pharmacologically active metabolite of alectinib.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Cmax of RO5468924
11.3 ng/mL
Standard Deviation 5.71
98.8 ng/mL
Standard Deviation 28.6
92.2 ng/mL
Standard Deviation 28.7
71.4 ng/mL
Standard Deviation 20.6
33.0 ng/mL
Standard Deviation 15.4
30.7 ng/mL
Standard Deviation 14.9
21.9 ng/mL
Standard Deviation 8.94
65.2 ng/mL
Standard Deviation 16.8

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Tmax is the time from alectinib administration to reach Cmax for RO5468924 (the major pharmacologically active metabolite of alectinib).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Tmax of RO5468924
8.07 hours
Interval 4.0 to 12.1
12.0 hours
Interval 6.0 to 24.0
10.0 hours
Interval 5.03 to 24.0
8.02 hours
Interval 6.0 to 12.1
8.00 hours
Interval 8.0 to 12.0
8.02 hours
Interval 6.0 to 12.1
8.00 hours
Interval 6.0 to 12.0
9.00 hours
Interval 5.0 to 24.0

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-inf) is the area under the RO5468924 plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in ng\*hour/mL.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
AUC(0-inf) of RO5468924
534 ng*hour/mL
Standard Deviation 279
3010 ng*hour/mL
Standard Deviation 819
2660 ng*hour/mL
Standard Deviation 687
2200 ng*hour/mL
Standard Deviation 578
968 ng*hour/mL
Standard Deviation 397
936 ng*hour/mL
Standard Deviation 419
754 ng*hour/mL
Standard Deviation 298
2100 ng*hour/mL
Standard Deviation 543

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-last) is the area under the RO5468924 plasma concentration versus time curve from time zero to the time of last measured concentration of RO5468924. RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng\*hour/mL.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
AUC(0-last) of RO5468924
392 ng*hour/mL
Standard Deviation 199
2780 ng*hour/mL
Standard Deviation 773
2460 ng*hour/mL
Standard Deviation 669
2000 ng*hour/mL
Standard Deviation 531
876 ng*hour/mL
Standard Deviation 375
826 ng*hour/mL
Standard Deviation 376
641 ng*hour/mL
Standard Deviation 248
1890 ng*hour/mL
Standard Deviation 477

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924
Alectinib
28.8 hours
Standard Deviation 17.4
19.8 hours
Standard Deviation 6.56
21.3 hours
Standard Deviation 10.6
21.4 hours
Standard Deviation 10.3
23.6 hours
Standard Deviation 11.1
24.3 hours
Standard Deviation 11.1
25.6 hours
Standard Deviation 11.2
21.9 hours
Standard Deviation 12.0
Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924
RO5468924
41.7 hours
Standard Deviation 19.8
28.3 hours
Standard Deviation 6.79
27.4 hours
Standard Deviation 5.27
29.1 hours
Standard Deviation 7.13
28.1 hours
Standard Deviation 8.29
30.7 hours
Standard Deviation 9.63
31.8 hours
Standard Deviation 12.7
31.0 hours
Standard Deviation 7.74

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

First-order terminal elimination rate constant (Kel) was calculated as the negative slope of the linear regression of the terminal phase in plasma alectinib and RO5468924 concentration versus time profile using appropriate time points. RO5468924 is the major pharmacologically active metabolite of alectinib.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Elimination Rate Constant (Kel) of Alectinib and RO5468924
RO5468924
0.0199 1/hour
Standard Deviation 0.00753
0.0256 1/hour
Standard Deviation 0.00493
0.0263 1/hour
Standard Deviation 0.00540
0.0252 1/hour
Standard Deviation 0.00618
0.0267 1/hour
Standard Deviation 0.00750
0.0248 1/hour
Standard Deviation 0.00767
0.0240 1/hour
Standard Deviation 0.00654
0.0236 1/hour
Standard Deviation 0.00538
Elimination Rate Constant (Kel) of Alectinib and RO5468924
Alectinib
0.0303 1/hour
Standard Deviation 0.0123
0.0371 1/hour
Standard Deviation 0.00732
0.0369 1/hour
Standard Deviation 0.0117
0.0371 1/hour
Standard Deviation 0.0117
0.0340 1/hour
Standard Deviation 0.0113
0.0333 1/hour
Standard Deviation 0.0119
0.0312 1/hour
Standard Deviation 0.0108
0.0367 1/hour
Standard Deviation 0.0110

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (\*) hour per liter (nmol\*hour/L).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)
4470 nmol*hour/L
Standard Deviation 2370
18400 nmol*hour/L
Standard Deviation 4600
16200 nmol*hour/L
Standard Deviation 3650
14300 nmol*hour/L
Standard Deviation 3570
6040 nmol*hour/L
Standard Deviation 2870
5780 nmol*hour/L
Standard Deviation 2290
5450 nmol*hour/L
Standard Deviation 2310
14100 nmol*hour/L
Standard Deviation 3490

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax
106 nmol/L
Standard Deviation 48.6
754 nmol/L
Standard Deviation 209
662 nmol/L
Standard Deviation 162
566 nmol/L
Standard Deviation 138
257 nmol/L
Standard Deviation 123
221 nmol/L
Standard Deviation 79.6
164 nmol/L
Standard Deviation 52.6
548 nmol/L
Standard Deviation 141

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-last) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib + RO5468924. AUC(0-last) is presented in nmol\*hour/L.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-last)
3740 nmol*hour/L
Standard Deviation 1560
17600 nmol*hour/L
Standard Deviation 4370
15400 nmol*hour/L
Standard Deviation 3500
13400 nmol*hour/L
Standard Deviation 3260
5660 nmol*hour/L
Standard Deviation 2620
5310 nmol*hour/L
Standard Deviation 1980
4780 nmol*hour/L
Standard Deviation 1710
13200 nmol*hour/L
Standard Deviation 3200

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Apparent Oral Clearance (CL/F) of Alectinib
449 liters/hour
Standard Deviation 199
113 liters/hour
Standard Deviation 30.9
126 liters/hour
Standard Deviation 31.5
141 liters/hour
Standard Deviation 39.3
377 liters/hour
Standard Deviation 149
380 liters/hour
Standard Deviation 152
383 liters/hour
Standard Deviation 151
141 liters/hour
Standard Deviation 40.2

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Apparent Volume of Distribution (Vz/F) of Alectinib
16500 liters
Standard Deviation 7300
3180 liters
Standard Deviation 1260
3730 liters
Standard Deviation 1530
4180 liters
Standard Deviation 1920
12200 liters
Standard Deviation 6240
12200 liters
Standard Deviation 5120
12900 liters
Standard Deviation 4430
4290 liters
Standard Deviation 2240

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

The AUC%extrap(0-inf), that is, area obtained after extrapolation (extrap) from time to last quantifiable plasma concentration (Tlast) to infinity is calculated by using the formula AUC%extrap(0-inf) = 100\*(AUC\[0-inf\] minus AUC\[0-last\])/AUC(0-inf); where AUC(0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUC(0-last) is area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration. The function of this parameter is to provide information about what percentage of the theoretical curve AUC(0-inf) was possible to determine experimentally (AUC0-last).

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924
Alectinib
12.5 percent AUC
Standard Deviation 10.9
3.04 percent AUC
Standard Deviation 2.57
4.24 percent AUC
Standard Deviation 5.01
4.49 percent AUC
Standard Deviation 4.86
6.43 percent AUC
Standard Deviation 4.06
7.45 percent AUC
Standard Deviation 6.25
9.91 percent AUC
Standard Deviation 8.08
4.52 percent AUC
Standard Deviation 5.54
Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924
RO5468924
26.0 percent AUC
Standard Deviation 11.2
7.84 percent AUC
Standard Deviation 2.57
7.84 percent AUC
Standard Deviation 2.52
9.12 percent AUC
Standard Deviation 3.39
10.2 percent AUC
Standard Deviation 3.67
12.6 percent AUC
Standard Deviation 6.14
14.9 percent AUC
Standard Deviation 6.89
9.94 percent AUC
Standard Deviation 3.93

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924
Alectinib
0.976 no units
Standard Deviation 0.0337
0.994 no units
Standard Deviation 0.00812
0.991 no units
Standard Deviation 0.0189
0.990 no units
Standard Deviation 0.0206
0.987 no units
Standard Deviation 0.0252
0.983 no units
Standard Deviation 0.0277
0.973 no units
Standard Deviation 0.0622
0.991 no units
Standard Deviation 0.0153
Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924
RO5468924
0.958 no units
Standard Deviation 0.0687
0.986 no units
Standard Deviation 0.0124
0.980 no units
Standard Deviation 0.0186
0.977 no units
Standard Deviation 0.0178
0.977 no units
Standard Deviation 0.0233
0.970 no units
Standard Deviation 0.0293
0.963 no units
Standard Deviation 0.0591
0.982 no units
Standard Deviation 0.0195

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)
0.34 ratio
Standard Deviation 0.0233
0.55 ratio
Standard Deviation 0.0468
0.56 ratio
Standard Deviation 0.0393
0.51 ratio
Standard Deviation 0.0290
0.54 ratio
Standard Deviation 0.0705
0.52 ratio
Standard Deviation 0.0720
0.43 ratio
Standard Deviation 0.0512
0.49 ratio
Standard Deviation 0.0300

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

AUC(0-last) is the area under the plasma concentration versus time curve from time zero to the time of last measured concentration. AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-last) is presented.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Molecular Weight Adjusted M/P Ratio for AUC(0-last)
0.29 ratio
Standard Deviation 0.0347
0.52 ratio
Standard Deviation 0.0474
0.54 ratio
Standard Deviation 0.0384
0.48 ratio
Standard Deviation 0.0264
0.52 ratio
Standard Deviation 0.0708
0.49 ratio
Standard Deviation 0.0838
0.41 ratio
Standard Deviation 0.0458
0.46 ratio
Standard Deviation 0.0237

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Molecular Weight Adjusted M/P Ratio for Cmax
0.28 ratio
Standard Deviation 0.0206
0.38 ratio
Standard Deviation 0.0445
0.42 ratio
Standard Deviation 0.0304
0.36 ratio
Standard Deviation 0.0223
0.33 ratio
Standard Deviation 0.0376
0.34 ratio
Standard Deviation 0.0446
0.33 ratio
Standard Deviation 0.0438
0.34 ratio
Standard Deviation 0.0207

SECONDARY outcome

Timeframe: Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose

Population: PK analysis set

Tlast is the time from alectinib administration to reach last quantifiable concentration of alectinib and its major pharmacologically active metabolite RO5468924.

Outcome measures

Outcome measures
Measure
Part 1 (Fasted): Treatment D
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=43 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=45 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 1 (Fasted): Treatment A
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 Participants
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment D
n=44 Participants
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924
Alectinib
96.0 hours
Interval 60.0 to 96.1
96.0 hours
Interval 72.1 to 96.1
96.0 hours
Interval 72.0 to 96.1
96.0 hours
Interval 72.0 to 96.1
96.0 hours
Interval 60.0 to 96.1
96.0 hours
Interval 60.0 to 96.1
96.0 hours
Interval 60.0 to 96.2
96.0 hours
Interval 72.0 to 96.2
Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924
RO5468924
72.0 hours
Interval 36.0 to 96.2
96.0 hours
Interval 96.0 to 96.1
96.0 hours
Interval 96.0 to 96.1
96.0 hours
Interval 96.0 to 96.1
96.0 hours
Interval 48.0 to 96.1
96.0 hours
Interval 48.0 to 96.0
96.0 hours
Interval 60.0 to 96.2
96.0 hours
Interval 96.0 to 96.2

Adverse Events

Part 1 (Fasted): Treatment A

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part 1 (Fasted): Treatment B

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part 1 (Fasted): Treatment C

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part 1 (Fasted): Treatment D

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part 2 (Fed): Treatment A

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part 2 (Fed): Treatment B

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part 2 (Fed): Treatment C

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 2 (Fed): Treatment D

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Part 1 (Fasted): Treatment A
n=47 participants at risk
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment B
n=45 participants at risk
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment C
n=46 participants at risk
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 1 (Fasted): Treatment D
n=47 participants at risk
Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
Part 2 (Fed): Treatment A
n=45 participants at risk
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment B
n=47 participants at risk
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment C
n=46 participants at risk
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
Part 2 (Fed): Treatment D
n=46 participants at risk
Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
Gastrointestinal disorders
Diarrhoea
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
4.3%
2/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Gastrointestinal disorders
Infrequent bowel movements
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
4.3%
2/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Gastrointestinal disorders
Constipation
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Infections and infestations
Respiratory tract infection
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Psychiatric disorders
Mood swings
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Ear and labyrinth disorders
Ear pain
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Eye disorders
Dry eye
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Nervous system disorders
Headache
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
4.4%
2/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
4.3%
2/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
General disorders
Thirst
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Infections and infestations
Oral herpes
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Investigations
Electrocardiogram abnormal
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
4.3%
2/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Investigations
Blood creatine phosphokinase increased
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Psychiatric disorders
Psychogenic respiratory distress
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.1%
1/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Infections and infestations
Upper respiratory tract infection
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Psychiatric disorders
Insomnia
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Renal and urinary disorders
Polyuria
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Gastrointestinal disorders
Nausea
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
General disorders
Fatigue
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Infections and infestations
Nasopharyngitis
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/45 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/47 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
0.00%
0/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
2.2%
1/46 • Day 1 through follow-up (up to 47 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER