Trial Outcomes & Findings for A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD (NCT NCT06309277)
NCT ID: NCT06309277
Last Updated: 2026-05-08
Results Overview
Clinical monitoring of safety data from AE reporting, 12-lead ECG, vital signs, clinical laboratory evaluations, emergence of suicidal thoughts and ideations (Columbia-Suicidal Severity Rating Scale) and sedation (Modified Observer's Assessment of Alertness and Sedation).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline, Day 29
Results posted on
2026-05-08
Participant Flow
Subjects with recurrent MDD with Montgomery-Asberg Depression Rating Scale (MADRS) score ≥23 and a CGI ≥ 4 were randomized. Participants had either been antidepressant-free for at least 6 weeks or were receiving an adequate dose of a single SSRI or SNRI for at least 6 weeks, prior to screening and had to maintain this treatment unchanged during the study. SAFER interviews verified MDD diagnosis and severity and antidepressant medication status.
Participant milestones
| Measure |
Treatment Sequence 1
Part A: GM-1020 140 mg → Placebo → Part B: GM-1020 140 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 2
Part A: GM-1020 140 mg → Placebo → Part B: GM-1020 210 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 3
Part A: Placebo → GM-1020 140 mg → Part B: GM-1020 140 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 4
Part A: Placebo → GM-1020 140 mg → Part B: GM-1020 210 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
11
|
10
|
|
Overall Study
Completed Treatment Part A Period 1
|
12
|
13
|
11
|
10
|
|
Overall Study
Completed Treatment Part A Period 2
|
10
|
13
|
9
|
9
|
|
Overall Study
Completed Treatment Part B
|
10
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
10
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1
n=12 Participants
Part A: GM-1020 140 mg → Placebo → Part B: GM-1020 140 mg This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 2
n=13 Participants
Part A: GM-1020 140 mg → Placebo → Part B: GM-1020 210 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 3
n=11 Participants
Part A: Placebo → GM-1020 140 mg → Part B: GM-1020 140 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Treatment Sequence 4
n=10 Participants
Part A: Placebo → GM-1020 140 mg → Part B: GM-1020 210 mg
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received GM-1020 140 mg p.o. or placebo (PBO) and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2). Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg p.o., twice a week for 2 weeks. Following completion of Part B, all participants were followed for 28 days.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=41 Participants
|
13 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
10 Participants
n=140 Participants
|
46 Participants
n=451 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
6 Participants
n=81 Participants
|
4 Participants
n=140 Participants
|
22 Participants
n=451 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=41 Participants
|
5 Participants
n=40 Participants
|
5 Participants
n=81 Participants
|
6 Participants
n=140 Participants
|
24 Participants
n=451 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=41 Participants
|
11 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
9 Participants
n=140 Participants
|
41 Participants
n=451 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
1 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
1 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=41 Participants
|
13 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
9 Participants
n=140 Participants
|
44 Participants
n=451 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
0 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=41 Participants
|
13 Participants
n=40 Participants
|
11 Participants
n=81 Participants
|
10 Participants
n=140 Participants
|
46 Participants
n=451 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 29Population: Safety analysis set, defined as all participants who receive at least one dose of study treatment.
Clinical monitoring of safety data from AE reporting, 12-lead ECG, vital signs, clinical laboratory evaluations, emergence of suicidal thoughts and ideations (Columbia-Suicidal Severity Rating Scale) and sedation (Modified Observer's Assessment of Alertness and Sedation).
Outcome measures
| Measure |
Part A, Placebo
n=44 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A, 140 mg
n=43 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
|
23 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Efficacy analysis set, defined as all randomized participants who receive at least one dose of study treatment and have at least one postdose efficacy datapoint.
The Structured Interview Guide for the Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms in patients. It consists of 10 items, each scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. Part A change from baseline MADRS was analyzed for Period 1 due to carryover effects as per SAP-defined analysis.
Outcome measures
| Measure |
Part A, Placebo
n=25 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A, 140 mg
n=20 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
|---|---|---|
|
MADRS Total Score Change From Baseline to 24 Hours
|
-12.138 Units on a scale
Interval -15.203 to -9.073
|
-5.85 Units on a scale
Interval -9.232 to -2.469
|
SECONDARY outcome
Timeframe: Day 8Population: Efficacy analysis set, defined as all randomized participants who receive at least one dose of study treatment and have at least one postdose efficacy datapoint.
The Structured Interview Guide for the Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale used to assess the severity of depressive symptoms in patients. It consists of 10 items, each scored from 0 to 6, yielding a total score ranging from 0 to 60, with higher scores indicating greater depression severity. Part A change from baseline MADRS was analyzed for Period 1 due to carryover effects as per SAP-defined analysis.
Outcome measures
| Measure |
Part A, Placebo
n=24 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A, 140 mg
n=19 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
|---|---|---|
|
MADRS Total Score Change From Baseline to Day 8
|
-10.467 Units on a scale
Interval -14.307 to -6.627
|
-5.386 Units on a scale
Interval -9.638 to -1.133
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 42Population: Efficacy analysis set, defined as all randomized participants who receive at least one dose of study treatment and have at least one postdose efficacy datapoint.
Observed percentage of participants with a MADRS total Score \<= 10.
Outcome measures
| Measure |
Part A, Placebo
n=18 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A, 140 mg
n=18 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
|---|---|---|
|
Part B Remission Rate, Day 42
|
38.9 Percentage of patients in remission
|
66.7 Percentage of patients in remission
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 67Population: Efficacy analysis set, defined as all randomized participants who receive at least one dose of study treatment and have at least one postdose efficacy datapoint.
Observed percentage of participants with a MADRS total Score \<= 10.
Outcome measures
| Measure |
Part A, Placebo
n=18 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A, 140 mg
n=18 Participants
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
|---|---|---|
|
Part B Remission Rate at Day 67
|
50.0 Percentage of participants in remission
|
66.7 Percentage of participants in remission
|
Adverse Events
Part A Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part A 140 mg
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Part B 140 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B 210 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A Placebo
n=44 participants at risk
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part A 140 mg
n=43 participants at risk
This proof-of-concept study had two parts: Part A was a randomized, double-blind, placebo-controlled, single-dose, cross-over study of GM-1020. In Part A Period 1, patients received a single oral dose of GM-1020 140 mg or placebo and were monitored for 2 weeks. Participants then received the cross-over treatment and were monitored for another 2 weeks (Part A Period 2).
|
Part B 140 mg
n=18 participants at risk
Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg, twice a week for 2 weeks. After Part B, all subjects were followed for an additional 28 days.
|
Part B 210 mg
n=19 participants at risk
Part B was a multiple-dose extension period; patients remained blinded to the treatment assignment and were randomized to receive GM-1020 at either 140 or 210 mg twice a week for 2 weeks. After Part B, all subjects were followed for an additional 28 days.
|
|---|---|---|---|---|
|
Psychiatric disorders
Flashback
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
21.1%
4/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
30.2%
13/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
44.4%
8/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
57.9%
11/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Illusion
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
34.9%
15/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
44.4%
8/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
52.6%
10/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Logorrhoea
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
9.3%
4/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
33.3%
6/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Time perception altered
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.6%
5/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
44.4%
8/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
63.2%
12/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Fatigue
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
4.7%
2/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
33.3%
6/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
42.1%
8/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling abnormal
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
20.9%
9/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
27.8%
5/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
52.6%
10/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling drunk
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.3%
7/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
38.9%
7/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
26.3%
5/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling hot
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
22.2%
4/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling of relaxation
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
25.6%
11/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
33.3%
6/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
36.8%
7/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Hangover
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
9.3%
4/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Slow speech
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Somnolence
|
4.5%
2/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
27.8%
5/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Tension headache
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Abnormal dreams
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Anxiety
|
4.5%
2/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Autoscopy
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Derealisation
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
4.7%
2/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
21.1%
4/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
44.2%
19/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
61.1%
11/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
57.9%
11/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
32.6%
14/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
31.6%
6/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
26.3%
5/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Eye disorders
Diplopia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Eye disorders
Vision blurred
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.6%
5/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
27.8%
5/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Eye disorders
Visual impairment
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
50.0%
9/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
15.8%
3/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
3/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Investigations
Amylase increased
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Renal and urinary disorders
Pollakiuria
|
2.3%
1/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Loss of Proprioception
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Synaesthesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Communication Disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Depersonalisation/derealisation disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Depression
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Dissociative identity disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Emotional poverty
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
22.2%
4/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Hallucination, synaesthetic
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Tachyphrenia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Asthenia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Chest pain
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Energy increased
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Feeling cold
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Influenza like illness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Medical device site reaction
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Pain
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Therapeutic product effect increased
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
General disorders
Thirst
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Infections and infestations
Oral herpes
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Cardiac disorders
Palpitations
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Surgical and medical procedures
Varicose vein operation
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
4.7%
2/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Lethargy
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.6%
5/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
33.3%
6/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
21.1%
4/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.3%
7/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
44.4%
8/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
36.8%
7/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
4.7%
2/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Headache
|
18.2%
8/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
37.2%
16/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
50.0%
9/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
42.1%
8/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
7.0%
3/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.6%
1/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
4.7%
2/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
0.00%
0/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Amnesia
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
14.0%
6/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
33.3%
6/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
21.1%
4/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Brain Fog
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
11.1%
2/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
5.3%
1/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
2.3%
1/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
16.7%
3/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
10.5%
2/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
9.3%
4/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
22.2%
4/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
26.3%
5/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
|
Nervous system disorders
Dizziness
|
4.5%
2/44 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
46.5%
20/43 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
50.0%
9/18 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
52.6%
10/19 • Part A: from Baseline to Day 29; Part B: from Day 29 to Day 67
|
Additional Information
Executive Director, Clinical Operations
Gilgamesh Pharma, Inc
Phone: (929) 723-4861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place