A Study of the Pharmacokinetics of MK-3682 and MK-8408 in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)



Status:Recruiting
Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:8/12/2016
Start Date:January 2016
End Date:September 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Two-Part, Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3682 and MK-8408 When Coadministered to Subjects With Moderate and Severe Hepatic Insufficiency

This is a 2-part, non-randomized, open-label, single-dose study to evaluate the
pharmacokinetics (PK) of MK-3682, its metabolites M5 and M6, and MK-8408 in participants
with moderate hepatic insufficiency (HI) (Part 1) and in participants with severe HI (Part
2) compared to those in matched healthy particpants.


Inclusion Criteria:

HI Participants Only:

- Has a diagnosis of chronic (>6 months), stable (no acute episodes of illness within
the previous 2 months due to deterioration in hepatic function) HI features of
cirrhosis;

- Part 1 only: Participant's score on the Child-Pugh scale ranges from 7 to 9 (moderate
HI) at study start.

- Part 2 only: Participant's score on the Child-Pugh scale ranges from 10 to 15 (severe
HI) at study start.

All Participants:

- Body mass index (BMI) ≥19 and ≤ 40 kg/m^2;

- Continuous non-smokers or moderate smokers (of fewer than 20 cigarettes/day or the
equivalent). Participants must agree to consume no more than 10 cigarettes or
equivalent/day from the time of screening and throughout the period of sample
collection;

- Health is judged to be stable based on medical history (except for the hepatic
impairment condition), physical examination, vital signs, electrocardiogram (ECGs),
and laboratory safety tests;

- For female participants of childbearing potential: either sexually inactive for 14
days prior to study start and throughout study or be using an acceptable birth
control method;

- Female participants who are sexually inactive, but become sexually active during the
course of the study must agree to use a double physical barrier method (e.g., condom
and diaphragm) and a chemical barrier (e.g., spermicide) from the time of the start
of sexual activity through completion of the study;

- Vasectomized or non-vasectomized male participants must agree to use a condom with
spermicide or abstain from sexual intercourse from dosing until 90 days after dosing;

- Male participants must agree not to donate sperm from dosing until 90 days after
dosing;

- Able to swallow multiple tablets and capsules.

Exclusion Criteria:

HI Participants Only:

- Presence of moderate or severe renal insufficiency (estimated glomerular filtration
rate [eGFR] ≤50 mL/min/1.73 m^2 calculated according to the Modification of Diet in
Renal Disease [MDRD] study equation);

- Presence of drug abuse within the past 6 months prior to dosing.

Healthy Participants Only:

- Presence of moderate or severe renal insufficiency (eGFR ≤60 mL/min/1.73 m^2
calculated according to the MDRD study equation);

- History or presence of alcoholism or drug abuse within the past 2 years prior to
dosing;

All Participants:

- Is mentally or legally incapacitated or has significant emotional problems at the
time of study start or expected during the study;

- History or presence of clinically significant medical or psychiatric condition or
disease;

- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs
or related compounds;

- Female participants who are pregnant or lactating;

- Positive results at study start for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg) or hepatitis C virus (HCV);

- Unable to refrain from or anticipates the use of any medication or substance
(including prescription or over-the-counter, vitamin supplements, natural or herbal
supplements) for the prohibited time period;

- Has taken amiodarone at any time in their life;

- Donation of blood >500 mL or had significant blood loss within 56 days prior to the
dose of study drugs;

- Plasma donation within 7 days prior to the dose of study drugs;

- Dosed in another clinical trial within 28 days prior to dosing of study drugs;
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