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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: Vibegron

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737684

4618-013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Participants With Moderate Hepatic Insufficiency

Experimental group

Description:

Participants with moderate hepatic insufficiency will receive a single oral dose of vibegron 100 mg.

Treatment:

Drug: Vibegron

Healthy Matched Control Participants

Experimental group

Description:

Participants who are healthy will receive a single oral dose of vibegron 100 mg.

Treatment:

Drug: Vibegron

Participants With Mild Hepatic Insufficiency

Experimental group

Description:

Participants with mild hepatic insufficiency will receive a single oral dose of vibegron 100 mg.

Treatment:

Drug: Vibegron