A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)

NCT01628042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-12-24

Study results available
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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.

Conditions

Interventions

DRUG

Vibegron 100 mg

Vibegron tablets, orally, on Day 1

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-16
Primary Completion
2013-01-25
Completion
2013-01-25

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01628042 on ClinicalTrials.gov