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

Phase 1

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Vibegron 100 mg

• Registration Number: NCT01628042
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Study Start: 2012-07-16
• Primary Completion: 2013-01-25
• Study Completion: 2013-01-25
• Results First Submitted: 2016-06-27
• Results First Submitted QC: 2016-06-27
• Results First Posted: 2016-08-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants With Mild Renal Insufficiency	Vibegron 100 mg	Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Participants With Severe Renal Insufficiency	Vibegron 100 mg	Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Participants With Moderate Renal Insufficiency	Vibegron 100 mg	Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Healthy Matched Control Participants	Vibegron 100 mg	Participants receive a single oral dose of vibegron 100 mg on Day 1.

Primary Outcome Measures

Name	Time	Method
Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose	Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose	Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.
Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose	Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.