Trial Outcomes & Findings for Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause (NCT NCT05325775)
NCT ID: NCT05325775
Last Updated: 2024-08-07
Results Overview
maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
COMPLETED
PHASE1/PHASE2
49 participants
Day 1
2024-08-07
Participant Flow
Participant milestones
| Measure |
ACER-801 50 mg BID
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Baseline characteristics by cohort
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 4.25 • n=93 Participants
|
55.6 years
STANDARD_DEVIATION 5.58 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 5.31 • n=27 Participants
|
56.5 years
STANDARD_DEVIATION 3.31 • n=483 Participants
|
56.2 years
STANDARD_DEVIATION 4.59 • n=36 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
12 participants
n=27 Participants
|
13 participants
n=483 Participants
|
49 participants
n=36 Participants
|
|
Frequency of vasomotor symptoms
|
11.77 daily number of symptoms
STANDARD_DEVIATION 1.898 • n=93 Participants
|
13.05 daily number of symptoms
STANDARD_DEVIATION 3.748 • n=4 Participants
|
11.58 daily number of symptoms
STANDARD_DEVIATION 1.932 • n=27 Participants
|
13.42 daily number of symptoms
STANDARD_DEVIATION 3.215 • n=483 Participants
|
12.46 daily number of symptoms
STANDARD_DEVIATION 2.70 • n=36 Participants
|
|
Severity of vasomotor symptoms / hot flash severity
|
2.28 score on a scale
STANDARD_DEVIATION 0.204 • n=93 Participants
|
2.36 score on a scale
STANDARD_DEVIATION 0.156 • n=4 Participants
|
2.28 score on a scale
STANDARD_DEVIATION 0.255 • n=27 Participants
|
2.39 score on a scale
STANDARD_DEVIATION 0.247 • n=483 Participants
|
2.33 score on a scale
STANDARD_DEVIATION 0.216 • n=36 Participants
|
|
Hot Flash Severity Score
|
26.89 score on a scale
STANDARD_DEVIATION 4.388 • n=93 Participants
|
30.43 score on a scale
STANDARD_DEVIATION 8.122 • n=4 Participants
|
26.35 score on a scale
STANDARD_DEVIATION 4.797 • n=27 Participants
|
31.86 score on a scale
STANDARD_DEVIATION 7.848 • n=483 Participants
|
28.88 score on a scale
STANDARD_DEVIATION 6.289 • n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ACER-801
|
10.78 ng/mL
Standard Deviation 8.97
|
32.36 ng/mL
Standard Deviation 33.56
|
41.75 ng/mL
Standard Deviation 30.69
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
maximum concentration of ACER-801 measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ACER-801
|
27.47 ng/mL
Standard Deviation 22.09
|
83.08 ng/mL
Standard Deviation 52.38
|
168.28 ng/mL
Standard Deviation 89.68
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
peak concentration of ACER-801 metabolite measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
|
15.25 ng/mL
Standard Deviation 11.60
|
43.77 ng/mL
Standard Deviation 44.58
|
61.31 ng/mL
Standard Deviation 38.44
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
peak concentration of ACER-801 metabolite measured at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Cmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of ACER-801 Metabolite
|
38.79 ng/mL
Standard Deviation 27.56
|
92.17 ng/mL
Standard Deviation 52.18
|
196.80 ng/mL
Standard Deviation 92.74
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
time to reach maximum concentration of ACER-801 measured at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of ACER-801
|
1.29 hour
Standard Deviation 0.66
|
1.21 hour
Standard Deviation 0.54
|
1.33 hour
Standard Deviation 0.58
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
time to reach maximum concentration of ACER-801 at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of ACER-801
|
0.96 hour
Standard Deviation 0.33
|
2.17 hour
Standard Deviation 1.45
|
1.79 hour
Standard Deviation 0.75
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
time to reach maximum concentration of ACER-801 metabolite at Day 1 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
|
1.38 hour
Standard Deviation 0.53
|
1.25 hour
Standard Deviation 0.54
|
1.33 hour
Standard Deviation 0.54
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Time to reach maximum concentration of ACER-801 metabolite at Day 14 Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only Tmax (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) of ACER-801 Metabolite
|
1.21 hour
Standard Deviation 0.45
|
2.21 hour
Standard Deviation 0.92
|
1.88 hour
Standard Deviation 0.61
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
|
42.32 h*ng/mL
Standard Deviation 37.02
|
149.92 h*ng/mL
Standard Deviation 159.83
|
205.94 h*ng/mL
Standard Deviation 156.95
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801
|
174.72 h*ng/mL
Standard Deviation 150.61
|
517.91 h*ng/mL
Standard Deviation 346.91
|
1252.54 h*ng/mL
Standard Deviation 769.07
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
|
61.42 h*ng/mL
Standard Deviation 46.41
|
172.18 h*ng/mL
Standard Deviation 165.54
|
291.23 h*ng/mL
Standard Deviation 203.43
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Area under the concentration time curve (AUC) from the time of dosing (0 hour) to the time of the last quantifiable (positive) concentration (Tlast) of ACER-801 metabolite, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method) Blood sampling included predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 hrs (prior to evening dose) and 15 hrs post morning dose. Only AUClast (mean, SD) data are available due to abbreviated data analyses.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From Dosing to the Time of the Last Measured Concentration (AUClast) of ACER-801 Metabolite
|
257.56 h*ng/mL
Standard Deviation 200.63
|
628.87 h*ng/mL
Standard Deviation 383.91
|
1579.25 h*ng/mL
Standard Deviation 847.47
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Terminal elimination half-life of ACER-801
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Half-life (T1/2) of ACER-801
|
5.17 hour
Standard Deviation 1.39
|
4.61 hour
Standard Deviation 1.26
|
4.80 hour
Standard Deviation 0.74
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Terminal elimination half-life of ACER-801
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Half-life (T1/2) of ACER-801
|
5.75 hour
Standard Deviation 1.05
|
5.06 hour
Standard Deviation 0.97
|
5.56 hour
Standard Deviation 1.15
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Terminal elimination half-life of ACER-801 metabolite
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Half-life (T1/2) of ACER-801 Metabolite
|
4.83 hour
Standard Deviation 1.30
|
4.83 hour
Standard Deviation 1.05
|
4.61 hour
Standard Deviation 0.66
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Terminal elimination half-life of ACER-801 metabolite
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Half-life (T1/2) of ACER-801 Metabolite
|
6.55 hour
Standard Deviation 1.41
|
5.57 hour
Standard Deviation 1.13
|
5.99 hour
Standard Deviation 1.55
|
—
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety Population
An Adverse Event (AE) is defined as any untoward medical occurrence associated with the use of the investigational product in humans, whether or not considered related to investigational product. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with any use of the investigational product, without any judgment about causality and irrespective of route of administration, formulation, or dose, including an overdose.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number and Percentage of Adverse Events ≥ 5%
|
17 events
|
21 events
|
23 events
|
21 events
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population
An AE is considered "serious" if, in the view of either the investigator or Acer, it results in any of the following outcomes: Death, Is immediately life threatening; Requires in-patient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Results in a congenital abnormality or birth defect; Is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number and Percentage of Serious Adverse Events (SAE)
|
0 event(s)
|
0 event(s)
|
1 event(s)
|
0 event(s)
|
PRIMARY outcome
Timeframe: Over 2 weeksPopulation: Safety population
Discontinuation or withdrawal from the study.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number and Percentage of Subjects Who Discontinued From the Study
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: At Day 14 relative to BaselinePopulation: Safety Population
A physician or appropriately qualified delegate conducted a full physical examination at baseline and at Day 14. The investigator decides if findings are considered abnormal at baseline and at Day 14 and whether the change is clinically significant. Only clinically significant changes will be reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Patients With a Clinically Significant Change From Baseline in Abnormalities Detected During Physical Examination
|
0 patients
|
0 patients
|
0 patients
|
0 patients
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Accumulation Ratio for Cmax (ARcmax) of ACER-801
|
4.87 ratio
Standard Deviation 6.36
|
4.38 ratio
Standard Deviation 4.69
|
4.76 ratio
Standard Deviation 1.78
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Accumulation Ratio for AUC (ARauc) of ACER-801
|
7.76 ratio
Standard Deviation 8.33
|
6.15 ratio
Standard Deviation 6.85
|
7.16 ratio
Standard Deviation 2.46
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
Cmax (maximum concentration) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Accumulation Ratio for Cmax (ARcmax) of ACER-801 Metabolite
|
4.28 ratio
Standard Deviation 4.76
|
2.70 ratio
Standard Deviation 1.48
|
3.51 ratio
Standard Deviation 1.29
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC (area under the curve) Accumulation Ratio calculated as Cmax,Day14/ Cmax,Day1 and AUCt,Day14/ AUCt,Day1, where the dosing interval t is 12h.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Accumulation Ratio for AUC (ARauc) of ACER-801 Metabolite
|
5.99 ratio
Standard Deviation 5.58
|
5.11 ratio
Standard Deviation 4.14
|
6.22 ratio
Standard Deviation 2.26
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). AUC = area under the curve
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Metabolite: Parent Ratio of AUC (MRauc)
|
1.97 ratio
Standard Deviation 1.33
|
1.34 ratio
Standard Deviation 0.34
|
1.53 ratio
Standard Deviation 0.33
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC (area under the curve) MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h).
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Metabolite: Parent Ratio of AUC (MRauc)
|
1.65 ratio
Standard Deviation 0.30
|
1.23 ratio
Standard Deviation 0.18
|
1.31 ratio
Standard Deviation 0.13
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). ACER-801 (parent); Cmax (maximum concentration)
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Metabolite:Parent Ratio of Cmax (MRcmax)
|
1.55 ratio
Standard Deviation 0.24
|
1.61 ratio
Standard Deviation 0.60
|
1.69 ratio
Standard Deviation 0.58
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
MR = Metabolite:Parent Ratio calculated as Cm,day14/ Cp,day1 and AUCt,m,day14/ AUCt,p,day1, where m and p are the metabolite and parent drug, respectively, and t is the dosing interval (12 h). ACER-801 (parent); Cmax (maximum concentration)
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Metabolite:Parent Ratio of Cmax (MRcmax)
|
1.55 ratio
Standard Deviation 0.24
|
1.15 ratio
Standard Deviation 0.19
|
1.23 ratio
Standard Deviation 0.17
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
|
53.50 h*ng/mL
Standard Deviation 48.08
|
173.72 h*ng/mL
Standard Deviation 178.05
|
247.19 h*ng/mL
Standard Deviation 181.87
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801
|
231.48 h*ng/mL
Standard Deviation 202.58
|
682.25 h*ng/mL
Standard Deviation 393.98
|
1673.06 h*ng/mL
Standard Deviation 1146.58
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
|
76.92 h*ng/mL
Standard Deviation 61.90
|
206.14 h*ng/mL
Standard Deviation 193.55
|
347.35 h*ng/mL
Standard Deviation 245.92
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects in the safety population who have sufficient plasma concentration above the limit of quantitation. PK is not tested in placebo arm.
AUC from the time of dosing (0 hour) extrapolated to infinity, calculated as AUClast + Clast/λz, where Clast was the last quantifiable concentration, and λz was the terminal elimination rate constant Reliability of AUCinf values was contingent upon AUCext and λz Profiles with AUCext ≤20% and a λz which met reporting criteria were considered reliable and AUCinf was reported. For profiles that did not meet these criteria, AUCinf and any parameter requiring AUCinf for computation were not reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Area Under the Concentration Curve From t0 to Infinite Time (AUCinf) of ACER-801 Metabolite
|
380.43 h*ng/mL
Standard Deviation 325.41
|
819.29 h*ng/mL
Standard Deviation 496.58
|
2270.60 h*ng/mL
Standard Deviation 1568.80
|
—
|
PRIMARY outcome
Timeframe: Over 2 weeksPopulation: Safety population; transient changes from normal to low or high values were reported but none were deemed clinically significant.
Blood samples will be measured for hemoglobin, hematocrit, white blood count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, red blood cell count (including mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration). Only clinically significant changes will be reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: HEMATOLOGY
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population; transient changes from normal to low or high values were reported but none were deemed clinically significant.
Blood samples will be measured for albumin, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, calcium, carbon dioxide, chloride, potassium, sodium, total cholesterol, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, phosphorus, total protein, uric acid. Only clinically significant changes will be reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: SERUM CHEMISTRY
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population; transient changes from normal to low or high values were reported but none were deemed clinically significant.
Blood samples will be measured for prothrombin time, partial thromboplastin time, international normalized ratio. Only clinically significant changes will be reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: COAGULATION
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population; transient changes from normal to low or high values were reported but none were deemed clinically significant.
Urine samples will be measured for pH, specific gravity, protein, glucose, ketones, bilirubin. Only clinically significant changes will be reported.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Number of Subjects With a Clinically Significant Change From Baseline for Clinical Laboratory Evaluations: URINALYSIS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population. Hormone testing was not conducted. Blood samples not available/collected for testing.
Blood samples not available/collected for testing. Blood samples will be measured for Bone Specific Alkaline Phosphatase (BSAP), osteocalcin, amino terminal propeptide of type 1 collagen (P1NP) and Collagen Type- C-Telopeptide (CTX). Only clinically significant changes will be reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety population. Hormone testing was not conducted. Blood samples not available/collected for testing.
Blood samples not available/collected for testing. Blood samples will be measured for catecholamines, vasopressin, gonadotropins, estradiol, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), cortisol, thyroid-stimulating hormone (TSH), T3 (Total and Free), T4 (Total and Free), prolactin, sex hormone binding globulin (SHBG), and insulin. Only clinically significant changes will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Week 1 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included. A negative change indicates a reduction.
Frequency is the number of vasomotor symptoms (hot flashes) recorded by the subject in the continuous diary. Week 1
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Frequency of Vasomotor Symptoms (Hot Flashes) From Baseline
|
-2.58 hot flashes
Standard Error 0.917
|
-2.81 hot flashes
Standard Error 0.918
|
-3.60 hot flashes
Standard Error 0.940
|
-3.39 hot flashes
Standard Error 0.898
|
SECONDARY outcome
Timeframe: At Week 2 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included. A negative change indicates a reduction.
Frequency is the number of vasomotor symptoms (hot flashes) recorded by the subject in the continuous diary. Week 2
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Frequency Vasomotor Symptoms (Hot Flashes) From Baseline
|
-3.30 hot flashes
Standard Error 0.947
|
-5.02 hot flashes
Standard Error 0.948
|
-5.15 hot flashes
Standard Error 0.970
|
-5.62 hot flashes
Standard Error 0.927
|
SECONDARY outcome
Timeframe: At Week 1 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included.
Patients recorded in a continuous diary the number of individual hot flashes experienced and rated the severity of each on a scale of mild, moderate, or severe where mild is assigned a value of 1, moderate a value of 2, and severe a value of 3 during data analysis. Daily severity was calculated as \[(1 × number of mild hot flashes) + (2 × number of moderate hot flashes) + (3 × number of severe hot flashes)\]/total number of hot flashes reported. The value at Week 1 was subtracted from the value at Baseline to yield the impact on severity score. A negative change indicates a reduction in severity.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
|
-0.20 score on a scale
Standard Error 0.067
|
-0.20 score on a scale
Standard Error 0.067
|
-0.24 score on a scale
Standard Error 0.067
|
-0.26 score on a scale
Standard Error 0.065
|
SECONDARY outcome
Timeframe: At Week 2 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included.
Patients recorded in a continuous diary the number of individual hot flashes experienced and rated the severity of each on a scale of mild, moderate, or severe where mild is assigned a value of 1, moderate a value of 2, and severe a value of 3 during data analysis. Daily severity was calculated as \[(1 × number of mild hot flashes) + (2 × number of moderate hot flashes) + (3 × number of severe hot flashes)\]/total number of hot flashes reported. The value at Week 2 was subtracted from the value at Baseline to yield the impact on severity score. A negative change indicates a reduction.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Severity of Vasomotor Symptoms (Hot Flashes) From Baseline
|
-0.31 score on a scale
Standard Error 0.091
|
-0.32 score on a scale
Standard Error 0.091
|
-0.43 score on a scale
Standard Error 0.091
|
-0.37 score on a scale
Standard Error 0.088
|
SECONDARY outcome
Timeframe: At Week 1 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included.
The hot flash severity score is a composite of the frequency and severity of hot flashes, and was calculated as follows: \[number of mild hot flashes on Day Y x 1\] + \[number of moderate hot flashes on Day Y x 2\] + \[number of severe hot flashes on Day Y x 3\]. The value at Week 1 was subtracted from the value at Baseline to yield the impact on the composite hot flash severity score. A negative change indicates a reduction.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Hot Flash Severity Score Vasomotor Symptoms From Baseline
|
-6.09 score on a scale
Standard Error 2.094
|
-7.45 score on a scale
Standard Error 2.082
|
-8.10 score on a scale
Standard Error 2.110
|
-8.56 score on a scale
Standard Error 2.043
|
SECONDARY outcome
Timeframe: At Week 2 relative to BaselinePopulation: Modified intent to treat population included all subjects in the safety population who had at least1 baseline and postbaseline result for an vasomotor symptom parameter. All patients were included.
The hot flash severity score is a composite of the frequency and severity of hot flashes, and was calculated as follows: \[number of mild hot flashes on Day Y x 1\] + \[number of moderate hot flashes on Day Y x 2\] + \[number of severe hot flashes on Day Y x 3\]. The value at Week 2 was subtracted from the value at Baseline to yield the impact on hot flash severity score. A negative change indicates a reduction in severity.
Outcome measures
| Measure |
ACER-801 50 mg BID
n=12 Participants
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 Participants
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 Participants
ACER-801 (osanetant) 200 mg BID (4 x 50 mg and 0 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 Participants
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Change in Hot Flash Severity Score of Vasomotor Symptoms From Baseline
|
-7.52 score on a scale
Standard Error 2.214
|
-12.47 score on a scale
Standard Error 2.200
|
-11.95 score on a scale
Standard Error 2.231
|
-13.67 score on a scale
Standard Error 2.159
|
Adverse Events
ACER-801 50 mg BID
ACER-801 100 mg BID
ACER-801 200 mg BID
Placebo
Serious adverse events
| Measure |
ACER-801 50 mg BID
n=12 participants at risk
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 participants at risk
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 participants at risk
ACER-801 (osanetant) 200 mg BID (3 x 50 mg and 1 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 participants at risk
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
Other adverse events
| Measure |
ACER-801 50 mg BID
n=12 participants at risk
ACER-801 (osanetant) 50 mg BID (1 x 50 mg and 3 x placebo, twice daily)
ACER-801 50 mg BID: 50 mg BID (twice daily)
|
ACER-801 100 mg BID
n=12 participants at risk
ACER-801 (osanetant) 100 mg BID (2 x 50 mg and 2 x placebo, twice daily)
ACER-801 100 mg BID: 100 mg BID (twice daily)
|
ACER-801 200 mg BID
n=12 participants at risk
ACER-801 (osanetant) 200 mg BID (3 x 50 mg and 1 x placebo, twice daily)
ACER-801 200 mg BID: 200 mg BID (twice daily)
|
Placebo
n=13 participants at risk
Placebo (4 x Placebo of ACER-801 twice daily)
Placebo: Placebo
|
|---|---|---|---|---|
|
General disorders
Vessel puncture site pain
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
15.4%
2/13 • Number of events 2 • 2 weeks
|
|
General disorders
Fatigue
|
0.00%
0/12 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
General disorders
Medical device site reaction
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
General disorders
infusion site haemorrhage
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
General disorders
sensation of foreign body
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
General disorders
vessel puncture site erythema
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
constipation
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
25.0%
3/12 • Number of events 3 • 2 weeks
|
33.3%
4/12 • Number of events 4 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
15.4%
2/13 • Number of events 2 • 2 weeks
|
|
Gastrointestinal disorders
diarrhoea
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/12 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
abdominal discomfort
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
breath odour
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
frequent bowl movements
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Nervous system disorders
headache
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
15.4%
2/13 • Number of events 2 • 2 weeks
|
|
Nervous system disorders
dizziness
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Nervous system disorders
syncope
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
15.4%
2/13 • Number of events 2 • 2 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
nasal dryness
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/12 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
xeroderma
|
0.00%
0/12 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Skin and subcutaneous tissue disorders
blister
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Cardiac disorders
palpitations
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
|
Blood and lymphatic system disorders
lymphadenitis
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Injury, poisoning and procedural complications
skin laceration
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
Renal and urinary disorders
micturition urgency
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
7.7%
1/13 • Number of events 1 • 2 weeks
|
|
General disorders
vessel puncture site swelling
|
8.3%
1/12 • Number of events 1 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
0.00%
0/13 • 2 weeks
|
Additional Information
Chief Medical Officer
Acer Therapeutics Inc ( a wholly owned subsidiary of Zevra Therapeutics Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place