Trial Outcomes & Findings for A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder (NCT NCT02395978)
NCT ID: NCT02395978
Last Updated: 2021-07-22
Results Overview
The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 extremely despondent\]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
From Baseline to Week 6
Results posted on
2021-07-22
Participant Flow
Subject were recruited over a 49-month period from April of 2015 to March of 2019 at 5 studies sites in Taiwan and 1 study site in the United States.
Participant milestones
| Measure |
Part I: 1 PDC-1421 Capsule
1 PDC-1421 Capsule thrice daily (TID), oral administration (p.o.) after meal for 28 days
|
Part I: 2 PDC-1421 Capsule
2 PDC-1421 Capsule TID, p.o. after meal for 28 days
|
Part II: 2 PDC-1421 Capsule
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
21
|
19
|
20
|
|
Overall Study
COMPLETED
|
6
|
6
|
19
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Part I: 1 PDC-1421 Capsule
n=6 Participants
1 PDC-1421 Capsule TID, p.o. after meal for 28 days
|
Part I: 2 PDC-1421 Capsule
n=6 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 28 days
|
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
n=6 Participants
|
43.2 years
n=6 Participants
|
43.1 years
n=21 Participants
|
42.1 years
n=19 Participants
|
43.9 years
n=20 Participants
|
42.7 years
n=72 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=19 Participants
|
8 Participants
n=20 Participants
|
27 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=19 Participants
|
12 Participants
n=20 Participants
|
45 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
0 participants
n=6 Participants
|
0 participants
n=6 Participants
|
3 participants
n=21 Participants
|
3 participants
n=19 Participants
|
4 participants
n=20 Participants
|
10 participants
n=72 Participants
|
|
Region of Enrollment
Taiwan
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
18 participants
n=21 Participants
|
16 participants
n=19 Participants
|
16 participants
n=20 Participants
|
62 participants
n=72 Participants
|
|
Weight
|
60.3 Kg
n=6 Participants
|
61.1 Kg
n=6 Participants
|
63 Kg
n=21 Participants
|
59.2 Kg
n=19 Participants
|
65 Kg
n=20 Participants
|
62.2 Kg
n=72 Participants
|
|
Height
|
162.5 cm
n=6 Participants
|
164.05 cm
n=6 Participants
|
163.8 cm
n=21 Participants
|
162.5 cm
n=19 Participants
|
165.2 cm
n=20 Participants
|
163.7 cm
n=72 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 6Population: The Intention-To-Treat (ITT) population consisted of 60 randomized subjects. The Per-Protocol (PP) population consisted of 44 randomized subjects. This Outcome Measure was conducted for Part II only.
The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 extremely despondent\]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II.
ITT population
|
-13.19 score on a scale
Standard Deviation 9.68
|
-9.21 score on a scale
Standard Deviation 8.32
|
-9.2 score on a scale
Standard Deviation 7.98
|
|
Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 Compared to Placebo for Part II.
PP population
|
-13.4 score on a scale
Standard Deviation 9.7
|
-10.4 score on a scale
Standard Deviation 5.18
|
-8.6 score on a scale
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 7Population: ITT population This Outcome Measure was conducted for Part II only.
The MADRS is a 10-item checklist of depressive symptoms. Each Item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 extremely despondent\]). The total MADRS score was calculated by summing the ratings of all items. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II.
From baseline to Week 2
|
-7.4 score on a scale
Standard Deviation 5.08
|
-6.4 score on a scale
Standard Deviation 8.87
|
-5.5 score on a scale
Standard Deviation 5.76
|
|
Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II.
From baseline to Week 4
|
-10.8 score on a scale
Standard Deviation 7.95
|
-7.6 score on a scale
Standard Deviation 9.12
|
-8.7 score on a scale
Standard Deviation 7.07
|
|
Change of Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 2, 4 and 7 Part II.
From baseline to Week 7
|
-13.6 score on a scale
Standard Deviation 8.98
|
-8.2 score on a scale
Standard Deviation 7.99
|
-9.9 score on a scale
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
HAM-D-17 scale is a clinician rated scale comprised of 17 items aimed at assessing depression severity among patients for treatment. Each item on the questionnaire is scored on a 3 point (8 items) or 5 point (9 items) scale, depending on the item. The total HAM-D-17 score was calculated by summing the ratings of all items. . The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression.
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 2
|
-7.9 score on a scale
Standard Deviation 4.72
|
-6.5 score on a scale
Standard Deviation 6.22
|
-4.3 score on a scale
Standard Deviation 4.58
|
|
Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 4
|
-9.7 score on a scale
Standard Deviation 6.03
|
-7.5 score on a scale
Standard Deviation 6.64
|
-8.2 score on a scale
Standard Deviation 4.72
|
|
Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 6
|
-11.0 score on a scale
Standard Deviation 6.71
|
-8.8 score on a scale
Standard Deviation 7.21
|
-8.7 score on a scale
Standard Deviation 6.91
|
|
Change of Hamilton Depression Rating Scale (HAM-D-17) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 7
|
-10.4 score on a scale
Standard Deviation 6.23
|
-7.9 score on a scale
Standard Deviation 7.05
|
-8.7 score on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
HAM-A is a series of questions related to symptoms of anxiety. It rates the individual on a five-point scale (0\~4) for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total HAM-A score was calculated by summing the ratings of all items. The total HAM-A score ranges from 0 to 56. The higher score represented a more severe measure of anxiety.
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 2
|
-5.4 score on a scale
Standard Deviation 3.06
|
-4.3 score on a scale
Standard Deviation 5.45
|
-2.9 score on a scale
Standard Deviation 4.66
|
|
Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 4
|
-7.2 score on a scale
Standard Deviation 5.95
|
-5.5 score on a scale
Standard Deviation 6.55
|
-6.2 score on a scale
Standard Deviation 4.82
|
|
Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 6
|
-8.7 score on a scale
Standard Deviation 6.04
|
-7.0 score on a scale
Standard Deviation 7.46
|
-6.2 score on a scale
Standard Deviation 6.30
|
|
Change of Hamilton Anxiety Rating Scale (HAM-A) Total Score From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 7
|
-8.9 score on a scale
Standard Deviation 5.82
|
-5.1 score on a scale
Standard Deviation 7.15
|
-6.6 score on a scale
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
DSSS includes a simultaneous measure of depression and somatic symptoms that two issues frequently co-occur. Consisting of 22 items, the DSSS includes 12 depression-related items (even items + item-21) and 10 somatic items (add items without item-21) - 5 of which query pain symptoms(item-1, 7, 11, 13, 17), forming a pain sub-scale. Each Item is rated on a scale of 0 (Absent) - 3 (Severe). DSSS Depression Sub-Score was calculated by summing the 12 depression-related items with ranges from 0 (absence of symptoms) to 36 (maximum severity). DSSS Somatic Sub-Score was calculated by summing the 10 somatin-related items with ranges from 0 (absence of symptoms) to 30 (maximum severity). DSSS Pain Sub-Score was calculated by summing the 5 pain-related items with ranges from 0 (absence of symptoms) to 15 (maximum severity).
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Depression Sub-Score- From baseline to Week 2
|
-3.6 score on a scale
Standard Deviation 5.26
|
-3.1 score on a scale
Standard Deviation 6.35
|
-1.7 score on a scale
Standard Deviation 3.15
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Depression Sub-Score- From baseline to Week 4
|
-4.5 score on a scale
Standard Deviation 5.36
|
-5.6 score on a scale
Standard Deviation 5.58
|
-4.0 score on a scale
Standard Deviation 5.20
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Depression Sub-Score- From baseline to Week 6
|
-4.7 score on a scale
Standard Deviation 7.71
|
-5.9 score on a scale
Standard Deviation 5.18
|
-3.6 score on a scale
Standard Deviation 5.09
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Depression Sub-Score- From baseline to Week 7
|
-5.4 score on a scale
Standard Deviation 6.46
|
-5.4 score on a scale
Standard Deviation 5.46
|
-3.3 score on a scale
Standard Deviation 5.51
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Somatic Sub-Score- From baseline to Week 2
|
-2.3 score on a scale
Standard Deviation 4.56
|
-2.2 score on a scale
Standard Deviation 4.11
|
-1.1 score on a scale
Standard Deviation 2.74
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Somatic Sub-Score- From baseline to Week 4
|
-2.6 score on a scale
Standard Deviation 5.3
|
-3.3 score on a scale
Standard Deviation 3.38
|
-0.9 score on a scale
Standard Deviation 2.21
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Somatic Sub-Score- From baseline to Week 6
|
-2.9 score on a scale
Standard Deviation 6.24
|
-3.3 score on a scale
Standard Deviation 3.94
|
-2.3 score on a scale
Standard Deviation 2.31
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Somatic Sub-Score- From baseline to Week 7
|
-3.1 score on a scale
Standard Deviation 4.90
|
-3.2 score on a scale
Standard Deviation 2.94
|
-1.3 score on a scale
Standard Deviation 2.62
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Pain Sub-Score- From baseline to Week 2
|
-0.9 score on a scale
Standard Deviation 2.46
|
-1.0 score on a scale
Standard Deviation 2.36
|
-0.4 score on a scale
Standard Deviation 2.01
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Pain Sub-Score- From baseline to Week 4
|
-1.2 score on a scale
Standard Deviation 2.79
|
-1.4 score on a scale
Standard Deviation 2.01
|
-0.6 score on a scale
Standard Deviation 1.93
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Pain Sub-Score- From baseline to Week 6
|
-1.3 score on a scale
Standard Deviation 3.23
|
-1.4 score on a scale
Standard Deviation 1.89
|
-1.2 score on a scale
Standard Deviation 1.76
|
|
Change of Depression and Somatic Symptoms Scale (DSSS) From Baseline to Week 2, 4, 6 and 7 for Part II
DSSS Pain Sub-Score- From baseline to Week 7
|
-1.3 score on a scale
Standard Deviation 2.41
|
-1.3 score on a scale
Standard Deviation 1.60
|
-0.5 score on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
CGI-Severity (CGI-S) is a 7-point scale which rates illness severity of psychopathology from 1 (normal, not at all ill) to 7 (among the most extremely ill).
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 2
|
-0.6 score on a scale
Standard Deviation 0.50
|
-0.7 score on a scale
Standard Deviation 0.95
|
-0.3 score on a scale
Standard Deviation 0.57
|
|
Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 4
|
-1.1 score on a scale
Standard Deviation 0.77
|
-0.9 score on a scale
Standard Deviation 1.2
|
-0.9 score on a scale
Standard Deviation 0.72
|
|
Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 6
|
-1.3 score on a scale
Standard Deviation 1.20
|
-1.0 score on a scale
Standard Deviation 1.00
|
-0.9 score on a scale
Standard Deviation 1.02
|
|
Change of Clinical Global Impression Scale - Severity (CGI-S) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 7
|
-1.4 score on a scale
Standard Deviation 1.12
|
-1.1 score on a scale
Standard Deviation 0.99
|
-1.0 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
Responder defined as a participant with ≧50% decrease from baseline in total score. Partial responder defined as a participant with a ≧25 and \<50% decrease from baseline in total score.
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 7 · Responder
|
11 Participants
|
4 Participants
|
6 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 2 · Responder
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 2 · Partial responder
|
9 Participants
|
3 Participants
|
4 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 2 · No response
|
10 Participants
|
12 Participants
|
14 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 4 · Responder
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 4 · Partial responder
|
8 Participants
|
5 Participants
|
8 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 4 · No response
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 6 · Responder
|
11 Participants
|
6 Participants
|
7 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 6 · Partial responder
|
3 Participants
|
8 Participants
|
4 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 6 · No response
|
7 Participants
|
5 Participants
|
9 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 7 · Partial responder
|
4 Participants
|
9 Participants
|
7 Participants
|
|
Percentage of Responders and Partial Responders in MADRS by Week 2, 4, 6 and 7 Weeks for Part II.
From baseline to Week 7 · No response
|
6 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From screen to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Ideation: The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present.
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 0 (baseline)
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 2
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 4
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 6
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Suicidal Ideations Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 7
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From screen to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
The FDA has adopted the 11 categories defined in the C-SSRS (Category 1 to 5 for suicidal ideation , Category 6 to 10 for suicidal behavior, and Category 11 for self-injurious behavior without suicidal intent) as their standard. Number of subjects with Suicidal Behavior: The maximum suicidal ideation category (6-10 on the C-SSRS) present at the assessment. Assign a score of 0 if no ideation is present.
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 0 (baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Suicidal Behaviors Collected by Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 2, 4, 6 and 7 for Part II.
Week 7
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, 4, 6 and 7Population: ITT population This Outcome Measure was conducted for Part II only.
CGI-Improvement (CGI-I) is a 7-point scale which rates illness has improved or worsened relative to a baseline state from 1 (Very much improved) to 7 (Very much worse).
Outcome measures
| Measure |
Part II: 2 PDC-1421 Capsule
n=21 Participants
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
PDC-1421 Capsule
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 Participants
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
PDC-1421 Capsule
placebo
|
Part II: 2 Placebo
n=20 Participants
2 placebo TID, p.o. after meal for 42 days
placebo
|
|---|---|---|---|
|
Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 2
|
3.0 score on a scale
Standard Deviation 0.84
|
3.1 score on a scale
Standard Deviation 1.03
|
3.4 score on a scale
Standard Deviation 0.60
|
|
Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 4
|
2.8 score on a scale
Standard Deviation 0.94
|
3.1 score on a scale
Standard Deviation 1.49
|
2.9 score on a scale
Standard Deviation 0.85
|
|
Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 6
|
2.8 score on a scale
Standard Deviation 1.44
|
2.8 score on a scale
Standard Deviation 1.18
|
2.9 score on a scale
Standard Deviation 1.17
|
|
Clinical Global Impression Scale -Improvement (CGI-I) From Baseline to Week 2, 4, 6 and 7 for Part II.
From baseline to Week 7
|
2.6 score on a scale
Standard Deviation 1.03
|
2.9 score on a scale
Standard Deviation 1.15
|
3.0 score on a scale
Standard Deviation 1.03
|
Adverse Events
Part I: 1 PDC-1421 Capsule
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: 2 PDC-1421 Capsule
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part II: 2 PDC-1421 Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part II: 2 Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part I: 1 PDC-1421 Capsule
n=6 participants at risk
1 PDC-1421 Capsule TID, p.o. after meal for 28 days
|
Part I: 2 PDC-1421 Capsule
n=6 participants at risk
2 PDC-1421 Capsule TID, p.o. after meal for 28 days
|
Part II: 2 PDC-1421 Capsule
n=21 participants at risk
2 PDC-1421 Capsule TID, p.o. after meal for 42 days
|
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
n=19 participants at risk
1 PDC-1421 Capsule plus 1 placebo TID, p.o. after meal for 42 days
|
Part II: 2 Placebo
n=20 participants at risk
2 placebo TID, p.o. after meal for 42 days
|
|---|---|---|---|---|---|
|
Eye disorders
Glaucoma
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Infections and infestations
Viral upper respirator tract infection
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
10.5%
2/19 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Cardiac disorders
Parlpitations
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
10.0%
2/20 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
9.5%
2/21 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
10.5%
2/19 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
15.0%
3/20 • Number of events 3 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
14.3%
3/21 • Number of events 3 • Part I: 5 weeks Part II: 7 weeks
|
15.8%
3/19 • Number of events 3 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
9.5%
2/21 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 6 • Part I: 5 weeks Part II: 7 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Investigations
Activated partial thromboplastin prolonged
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Nuchal rigidity
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
9.5%
2/21 • Number of events 3 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
5.3%
1/19 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 2 • Part I: 5 weeks Part II: 7 weeks
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/21 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
5.0%
1/20 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/6 • Part I: 5 weeks Part II: 7 weeks
|
4.8%
1/21 • Number of events 1 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/19 • Part I: 5 weeks Part II: 7 weeks
|
0.00%
0/20 • Part I: 5 weeks Part II: 7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place