CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Vibegron 100 mgdrug
Likely dose
Vibegron 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01628042
NCT01628042Phase 1Completed
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An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency

Merck Sharp & Dohme LLC·interventional·Posted Jun 26, 2012·Updated Dec 24, 2018

In Brief

A Phase 1 clinical trial evaluating Vibegron 100 mg for Overactive Bladder. Completed, enrolled 32 participants.

Detailed Summary

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2012
Enrollment StartJul 16, 2012
Primary CompletionJan 25, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.0 years ago

Interventions

Vibegron 100 mgdrug

Vibegron tablets, orally, on Day 1