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

NCT01737684 | Completed Phase 1 Results

• 1 other identifier: 4618-013
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Secondary Outcomes (5)

• Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

• Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

• Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

• Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

• Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg

  Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose

Study Arms (3)

Participants With Moderate Hepatic Insufficiency

EXPERIMENTAL

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

Drug: Vibegron

Healthy Matched Control Participants

EXPERIMENTAL

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

Drug: Vibegron

Participants With Mild Hepatic Insufficiency

EXPERIMENTAL

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

Drug: Vibegron

Interventions

Vibegron DRUG

50 mg tablet, oral

Also known as: MK-4618

Healthy Matched Control Participants; Participants With Mild Hepatic Insufficiency; Participants With Moderate Hepatic Insufficiency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: January 15, 2013
• Primary Completion: June 14, 2013
• Study Completion: June 14, 2013
• Last Updated: December 24, 2018
• Results First Posted: June 22, 2016

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share