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
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
- lead INDUSTRY
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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