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Completed

NCT Number: NCT01737684

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibegron

Drug

50 mg tablet, oral

Other names: MK-4618

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Two-Part, Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Hepatic Insufficiency

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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