Trial Outcomes & Findings for A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004) (NCT NCT01500382)
NCT ID: NCT01500382
Last Updated: 2018-12-24
Results Overview
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
TERMINATED
PHASE1
4 participants
Baseline (pre-dose Day 1) and Day 7 (post-dose)
2018-12-24
Participant Flow
Participant milestones
| Measure |
Vibegron 100 mg + Tolterodine 4 mg → Placebo
During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
|
Placebo → Vibegron 100 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
|
Placebo → Tolterodine 4 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
|
Placebo → Vibegron 50 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
1
|
1
|
1
|
1
|
|
Treatment Period 1
COMPLETED
|
1
|
1
|
1
|
1
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
1
|
1
|
1
|
1
|
|
Washout Period
COMPLETED
|
1
|
1
|
0
|
1
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
1
|
1
|
0
|
1
|
|
Treatment Period 2
COMPLETED
|
1
|
1
|
0
|
1
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vibegron 100 mg + Tolterodine 4 mg → Placebo
During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
|
Placebo → Vibegron 100 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
|
Placebo → Tolterodine 4 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
|
Placebo → Vibegron 50 mg
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
|
|---|---|---|---|---|
|
Washout Period
Study site went out of business
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)
Baseline characteristics by cohort
| Measure |
Vibegron 100 mg + Tolterodine 4 mg → Placebo
n=1 Participants
During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
|
Placebo → Vibegron 100 mg
n=1 Participants
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
|
Placebo → Tolterodine 4 mg
n=1 Participants
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
|
Placebo → Vibegron 50 mg
n=1 Participants
During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION NA • n=5 Participants
|
61 Years
STANDARD_DEVIATION NA • n=7 Participants
|
55 Years
STANDARD_DEVIATION NA • n=5 Participants
|
68 Years
STANDARD_DEVIATION NA • n=4 Participants
|
58.3 Years
STANDARD_DEVIATION 8.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
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
|
PRIMARY outcome
Timeframe: Baseline (pre-dose Day 1) and Day 7 (post-dose)Population: Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)Population: The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Outcome measures
| Measure |
Vibegron 100 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
|
Vibegron 100 mg + Tolterodine ER 4 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
|
Vibegron 50 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
|
Placebo
n=4 Participants
Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)Population: The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.
Outcome measures
| Measure |
Vibegron 100 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
|
Vibegron 100 mg + Tolterodine ER 4 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
|
Vibegron 50 mg
n=1 Participants
Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
|
Placebo
n=4 Participants
Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Use of Study Drug Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Day 1) and Day 7 (post-dose)Population: Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
Outcome measures
Outcome data not reported
Adverse Events
Vibegron 100 mg
Vibegron 100 mg + Tolterodine ER 4 mg
Vibegron 50 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER