A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2022-01-25

Brief Summary

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The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic impairment to healthy participants.

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Detailed Description

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Conditions

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Hepatic Impairment

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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Moderate Hepatic Impairment Participants

Participants with hepatic impairment will receive a single dose of MK-8189 4 mg orally on Day 1.

Group Type EXPERIMENTAL

MK-8189

Intervention Type DRUG

Administered at a dose of 4 mg via oral tablet

Healthy Participants

Healthy participants will receive a single dose of MK-8189 4 mg orally on Day 1.

Group Type EXPERIMENTAL

MK-8189

Intervention Type DRUG

Administered at a dose of 4 mg via oral tablet

Interventions

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MK-8189

Administered at a dose of 4 mg via oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
* Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
* (For hepatically impaired participants) Has a diagnosis of chronic (\>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment

Exclusion Criteria

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
* Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
* Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
* Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
* Consumes greater than 3 glasses of alcoholic beverages per day
* Consumes greater than 6 servings (1 serving is \~120 mg of caffeine) caffeinated beverages per day
* (For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes