Trial Outcomes & Findings for AGN-241751 in the Treatment of Major Depressive Disorder (NCT NCT03726658)
NCT ID: NCT03726658
Last Updated: 2023-07-07
Results Overview
Efficacy will be measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement. Results are reported as change from baseline in treated group compared to change from baseline in placebo, reported as least squares difference and (standard error) calculated from a mixed model-repeated measures analysis
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
226 participants
Primary outcome timeframe
Baseline (Day1) to Day 2
Results posted on
2023-07-07
Participant Flow
Participant milestones
| Measure |
AGN-241751 3mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
26
|
25
|
40
|
40
|
41
|
|
Overall Study
COMPLETED
|
25
|
26
|
24
|
25
|
34
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
AGN-241751 3mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
6
|
4
|
2
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Not Reported
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AGN-241751 in the Treatment of Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
AGN-241751 3mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
n=25 Participants
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
n=40 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
n=40 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
n=41 Participants
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 13.84 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 12.43 • n=4 Participants
|
38.5 years
STANDARD_DEVIATION 12.62 • n=21 Participants
|
40.3 years
STANDARD_DEVIATION 14.21 • n=8 Participants
|
37.7 years
STANDARD_DEVIATION 14.06 • n=8 Participants
|
40.2 years
STANDARD_DEVIATION 13.78 • n=24 Participants
|
|
Sex: Female, Male
Part A · Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
112 Participants
n=24 Participants
|
|
Sex: Female, Male
Part A · Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
112 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
103 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
108 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
25 participants
n=4 Participants
|
40 participants
n=21 Participants
|
40 participants
n=8 Participants
|
41 participants
n=8 Participants
|
224 participants
n=24 Participants
|
|
Montgomery-Asberg Depression Severity (MADRS) score at baseline (prior to first dose)
|
34.0 units on a scale
STANDARD_DEVIATION 4.48 • n=5 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 4.51 • n=7 Participants
|
33.3 units on a scale
STANDARD_DEVIATION 5.02 • n=5 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 4.20 • n=4 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 3.62 • n=21 Participants
|
34.2 units on a scale
STANDARD_DEVIATION 4.12 • n=8 Participants
|
33.8 units on a scale
STANDARD_DEVIATION 5.05 • n=8 Participants
|
34.06 units on a scale
STANDARD_DEVIATION 0.509 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day1) to Day 2Population: Modified Intent-to-Treat
Efficacy will be measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement. Results are reported as change from baseline in treated group compared to change from baseline in placebo, reported as least squares difference and (standard error) calculated from a mixed model-repeated measures analysis
Outcome measures
| Measure |
AGN-241751 3mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
n=25 Participants
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Part A: Change in MADRS Score at 1 Day the Initial Dose of AGN-241751 Reported as Change From Baseline in Treated Group Compared With Change From Baseline in Placebo Group
|
-9.4 score on a scale
Standard Error 1.57
|
-6.7 score on a scale
Standard Error 1.58
|
-9.5 score on a scale
Standard Error 1.57
|
-9.3 score on a scale
Standard Error 1.61
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Day 8Population: Modified Intent-to-Treat, subjects who completed Day 8 assessments
Efficacy was measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement.
Outcome measures
| Measure |
AGN-241751 3mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
n=37 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
n=38 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
n=40 Participants
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in MADRS Score at Day 8 Post the Initial Dose of AGN-241751 (i.e. 1 Day After the Seventh Daily Dose)
|
—
|
—
|
—
|
—
|
-12.8 score on a scale
Standard Error 1.53
|
-10.5 score on a scale
Standard Error 1.52
|
-10.9 score on a scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 22Population: Modified Intent-to-Treat
Efficacy was measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement.
Outcome measures
| Measure |
AGN-241751 3mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
n=26 Participants
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
n=25 Participants
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in MADRS Score on Day 9 and Day 15 of AGN-241751 Once Daily and at Day 22 (7 Days After Completion of AGN-241751 Dosing) Compared With Change in Placebo
Day 9
|
-13.0 score on a scale
Standard Error 1.86
|
-13.6 score on a scale
Standard Error 1.87
|
-14.1 score on a scale
Standard Error 1.85
|
-12.0 score on a scale
Standard Error 1.89
|
—
|
—
|
—
|
|
Part A: Change From Baseline in MADRS Score on Day 9 and Day 15 of AGN-241751 Once Daily and at Day 22 (7 Days After Completion of AGN-241751 Dosing) Compared With Change in Placebo
Day 22
|
-12.5 score on a scale
Standard Error 1.97
|
-11.8 score on a scale
Standard Error 1.91
|
-14.5 score on a scale
Standard Error 1.90
|
-13.6 score on a scale
Standard Error 1.94
|
—
|
—
|
—
|
|
Part A: Change From Baseline in MADRS Score on Day 9 and Day 15 of AGN-241751 Once Daily and at Day 22 (7 Days After Completion of AGN-241751 Dosing) Compared With Change in Placebo
Day 15
|
-13.2 score on a scale
Standard Error 1.86
|
-13.7 score on a scale
Standard Error 1.87
|
-13.2 score on a scale
Standard Error 1.89
|
-11.6 score on a scale
Standard Error 1.90
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 21Population: Modified Intent to Treat
Efficacy was measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement. Results are reported as change from baseline in treated group compared to change from baseline in placebo, reported as least squares difference and (standard error) calculated from a mixed model-repeated measures analysis
Outcome measures
| Measure |
AGN-241751 3mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
n=37 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
n=38 Participants
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
n=40 Participants
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in MADRS Score on Day 11, Day 14, and Day 18 of AGN-241751 Administered Two Times Daily and on Day 21 (7 Days After Completion of Dosing) in Treated Group Compared to Change From Baseline in Placebo Group
Day 11
|
—
|
—
|
—
|
—
|
-15.8 score on a scale
Standard Error 1.70
|
-15.2 score on a scale
Standard Error 1.72
|
-14.0 score on a scale
Standard Error 1.67
|
|
Part B: Change From Baseline in MADRS Score on Day 11, Day 14, and Day 18 of AGN-241751 Administered Two Times Daily and on Day 21 (7 Days After Completion of Dosing) in Treated Group Compared to Change From Baseline in Placebo Group
Day 14
|
—
|
—
|
—
|
—
|
-17.0 score on a scale
Standard Error 1.76
|
-15.3 score on a scale
Standard Error 1.82
|
-14.7 score on a scale
Standard Error 1.71
|
|
Part B: Change From Baseline in MADRS Score on Day 11, Day 14, and Day 18 of AGN-241751 Administered Two Times Daily and on Day 21 (7 Days After Completion of Dosing) in Treated Group Compared to Change From Baseline in Placebo Group
Day 18
|
—
|
—
|
—
|
—
|
-18.3 score on a scale
Standard Error 1.88
|
-15.0 score on a scale
Standard Error 1.98
|
-16.9 score on a scale
Standard Error 1.86
|
|
Part B: Change From Baseline in MADRS Score on Day 11, Day 14, and Day 18 of AGN-241751 Administered Two Times Daily and on Day 21 (7 Days After Completion of Dosing) in Treated Group Compared to Change From Baseline in Placebo Group
Day 21
|
—
|
—
|
—
|
—
|
-17.3 score on a scale
Standard Error 1.79
|
-16.5 score on a scale
Standard Error 1.84
|
-16.5 score on a scale
Standard Error 1.74
|
Adverse Events
AGN-241751 3mg Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AGN-241751 10mg Daily
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
AGN-241751 25mg Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AGN-241751 3mg Two Times Per Day
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
AGN-241751 25mg Two Times Per Day
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo 2 Times Per Day
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-241751 3mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
n=25 participants at risk
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
n=41 participants at risk
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
n=41 participants at risk
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
n=41 participants at risk
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion Induced
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/25 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/41 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/41 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
2.4%
1/41 • Number of events 1 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
Other adverse events
| Measure |
AGN-241751 3mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 10mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Daily
n=26 participants at risk
AGN-241751, oral administration, once per day in Part A.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo Daily
n=25 participants at risk
Placebo, oral administration, once per day in part A.
Placebo: Placebo is supplied in tablet form
|
AGN-241751 3mg Two Times Per Day
n=41 participants at risk
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
AGN-241751 25mg Two Times Per Day
n=41 participants at risk
AGN-241751, oral administration, BID in Part B.
AGN-241751: AGN-241751 is supplied in tablet form
|
Placebo 2 Times Per Day
n=41 participants at risk
Placebo, oral administration, two times per day in part B.
Placebo: Placebo is supplied in tablet form
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
15.4%
4/26 • Number of events 4 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
19.2%
5/26 • Number of events 5 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
15.4%
4/26 • Number of events 4 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
12.0%
3/25 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
14.6%
6/41 • Number of events 6 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
24.4%
10/41 • Number of events 10 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
34.1%
14/41 • Number of events 14 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
11.5%
3/26 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
7.7%
2/26 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/25 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
2.4%
1/41 • Number of events 1 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
14.6%
6/41 • Number of events 6 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
4.9%
2/41 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/25 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
7.3%
3/41 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
4.9%
2/41 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
7.3%
3/41 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
|
Nervous system disorders
Abnormal Dreams
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/25 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
7.3%
3/41 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
4.9%
2/41 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
4.9%
2/41 • Number of events 2 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/26 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/25 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
7.3%
3/41 • Number of events 3 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
0.00%
0/41 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
2.4%
1/41 • Number of events 1 • Two weeks = 14 days
NOTE: All values for number of participants at risk include all participants randomized, which is greater than the number of participants who received at least one dose of drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60