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

• Status: Completed
• Trial end date: 2013-06-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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