A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)

Merck Sharp & Dohme LLC16 enrolled

Overview

This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.

This study is planned to be conducted in two parts. Part 1 of the study will include participants with moderate hepatic insufficiency and healthy participants. If Part 2 is conducted, Part 2 of the study will include participants with mild hepatic insufficiency.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

VibegronDRUG

50 mg tablet, oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria For both healthy participants and participants with hepatic insufficiency: * Continuous non-smokers who haven't used nicotine-containing products for at least 3 months prior to study drug administration * Body mass index (BMI) ≤39 kg/m\^2 * Good health based on medical history, physical examination, vital signs, laboratory safety tests, and electrocardiogram (ECG) * Females of childbearing potential must be sexually inactive for 14 days prior to study drug administration and throughout study or use acceptable birth control method * Females of non-childbearing potential must have undergone an acceptable sterilization procedure at least 6 months prior to Day 1 of study or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 * Non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after study drug administration For participants with hepatic insufficiency only: * Diagnosis of chronic, stable, hepatic insufficiency * For Part 1 Participants: Child-Pugh scale range from 7 to 9 * For Part 2 Participants: Child-Pugh scale range from 5 to 6

Outcomes

Primary Outcomes

Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg