Trial Outcomes & Findings for Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women (NCT NCT01829919)
NCT ID: NCT01829919
Last Updated: 2015-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1
Results posted on
2015-10-15
Participant Flow
Participant milestones
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules
All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=99 Participants
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Age, Categorical
>=65 years
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4 Participants
n=99 Participants
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Age, Continuous
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56.2 years
STANDARD_DEVIATION 7.29 • n=99 Participants
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Sex: Female, Male
Female
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24 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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24 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 1Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
AUC0-last (Hour x ng/mL)
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86.95 Hour*ng/mL
Standard Deviation 166.19
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AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
AUC0-inf (Hour x ng/mL)
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78.80 Hour*ng/mL
Standard Deviation 189.88
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AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
AUC0-24 (Hour x ng/mL)
|
38.90 Hour*ng/mL
Standard Deviation 51.83
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PRIMARY outcome
Timeframe: Day 1Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
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2.77 ng/mL
Standard Deviation 3.38
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PRIMARY outcome
Timeframe: Day 1Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
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0.05 Hour^(-1)
Standard Deviation 0.01
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PRIMARY outcome
Timeframe: Day 1Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg
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17.30 Hours
Standard Deviation 11.45
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PRIMARY outcome
Timeframe: Day 1Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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6.00 hours
Interval 1.0 to 8.0
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
AUC0-last (Hour x ng/mL)
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237.34 Hour*ng/mL
Standard Deviation 222.65
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AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
AUC0-24 (Hour x ng/mL)
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237.28 Hour*ng/mL
Standard Deviation 222.64
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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13.10 ng/mL
Standard Deviation 11.92
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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7.67 ng/mL
Standard Deviation 7.57
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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6.00 Hours
Interval 3.0 to 8.0
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19
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9.71 Ratio
Interval 0.12 to 23.48
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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75.76 Percentage of steady state concentration
Interval 35.57 to 153.2
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
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9.89 ng/mL
Standard Deviation 9.28
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PRIMARY outcome
Timeframe: Day 19Population: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
C(t) is the measured plasma level "Concentration" of the drug at "time = t" expressed as nanograms per milliliter.
Outcome measures
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
n=24 Participants
Brisdelle (paroxetine mesylate) Capsules 7.5 mg
All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
Cτ18 (ng/mL)
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8.53 ng/mL
Standard Deviation 9.17
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Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
Cτ19 (ng/mL)
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8.35 ng/mL
Standard Deviation 8.49
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Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg
Cτ20 (ng/mL)
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8.79 ng/mL
Standard Deviation 9.19
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Adverse Events
Brisdelle (Paroxetine Mesylate) Capsules
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brisdelle (Paroxetine Mesylate) Capsules
n=24 participants at risk
Brisdelle (paroxetine mesylate) Capsules
All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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12.5%
3/24 • Number of events 3 • 21 days
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Gastrointestinal disorders
Constipation
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20.8%
5/24 • Number of events 6 • 21 days
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Gastrointestinal disorders
Diarrhoea
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12.5%
3/24 • Number of events 3 • 21 days
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General disorders
Fatigue
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25.0%
6/24 • Number of events 6 • 21 days
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Musculoskeletal and connective tissue disorders
Back pain
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12.5%
3/24 • Number of events 3 • 21 days
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Nervous system disorders
Headache
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16.7%
4/24 • Number of events 7 • 21 days
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Psychiatric disorders
Abnormal dreams
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12.5%
3/24 • Number of events 3 • 21 days
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Psychiatric disorders
Insomnia
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12.5%
3/24 • Number of events 3 • 21 days
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Skin and subcutaneous tissue disorders
Hyperhidrosis
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12.5%
3/24 • Number of events 3 • 21 days
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Additional Information
Sailaja Bhaskar, Executive Director, Clinical Research
Noven Therapeutics, LLC
Phone: (212) 287-0798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER