An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency
Overview
- Phase
- Phase 1
- Intervention
- Vibegron 100 mg
- Conditions
- Overactive Bladder
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 32
- Primary Endpoint
- Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Participants With Severe Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Intervention: Vibegron 100 mg
Participants With Moderate Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Intervention: Vibegron 100 mg
Participants With Mild Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
Intervention: Vibegron 100 mg
Healthy Matched Control Participants
Participants receive a single oral dose of vibegron 100 mg on Day 1.
Intervention: Vibegron 100 mg
Outcomes
Primary Outcomes
Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg
Time Frame: 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
Time Frame: 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
Time Frame: 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.