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

NCT ID: NCT01737684

Last Updated: 2018-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-15

Study Completion Date

2013-06-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants With Moderate Hepatic Insufficiency

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

Group Type EXPERIMENTAL

Vibegron

Intervention Type DRUG

50 mg tablet, oral

Healthy Matched Control Participants

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

Group Type EXPERIMENTAL

Vibegron

Intervention Type DRUG

50 mg tablet, oral

Participants With Mild Hepatic Insufficiency

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

Group Type EXPERIMENTAL

Vibegron

Intervention Type DRUG

50 mg tablet, oral

Interventions

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Vibegron

50 mg tablet, oral

Intervention Type DRUG

Other Intervention Names

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MK-4618

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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United States

Other Identifiers

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4618-013

Identifier Type: -

Identifier Source: org_study_id