Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:5/14/2016
Start Date:January 2016
End Date:July 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-3682B (MK-3682/MK-5172/MK-8408 Fixed Dose Combination) When Administered to Subjects With Moderate and Severe Renal Insufficiency

The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of
MK-3682B (MK-3682/MK-5172/MK-8408 fixed dose combination [FDC]) in participants with
moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to healthy participants.


Inclusion Criteria:

All Participants:

- Healthy adult males or females 18-80 years of age at screening

- Continuous non-smokers or moderate smokers (≤ 20 cigarettes/day or the equivalent)
and agrees to consume no more than 10 cigarettes per day during the study period

- Body Mass Index (BMI) ≥ 18 and ≤ 40.0 kg/m2

- Agrees not to become pregnant or father a child during participation in the study

- Females of childbearing potential must either be abstinent for 14 days prior to
dosing and throughout the study or be using an acceptable birth control method

- Vasectomized or non-vasectomized males must agree to use a condom with spermicide or
abstain from sexual intercourse from the first dose until 90 days after dosing

- Males must agree not to donate sperm from dosing until 90 days after dosing

Moderate and Severe RI Participants:

- Baseline health is judged to be stable based on medical history, physical
examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as
deemed by the Investigator

- Has had no clinically significant change in renal status at least 1 month prior to
dosing and is not currently or has not previously been on hemodialysis

- Moderate RI: has baseline eGFR ≥ 30 mL/min/1.73m2 and < 60 mL/min/1.73m2, based on
the Modification of Diet in Renal Disease (MDRD) equation at screening

- Severe RI: has baseline eGFR ≥ 15 mL/min/1.73m2 and < 30 mL/min/1.73m2, based on the
MDRD equation at screening

Healthy Participants:

- Is within ± 10 years of the mean age of moderate and severe RI arms

- BMI is within 10% of the mean BMI of participants with moderate and severe RI arms

- Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs, or ECGs, as deemed by the Investigator

- Baseline CLcr ≥ 80 mL/min based on Cockcroft-Gault equation at screening

Exclusion Criteria:

- Is mentally or legally incapacitated or has significant emotional problems at the
time of the screening

- History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the Investigator

- History of any illness that, in the opinion of the Investigator, might confound the
results of the study or poses an additional risk by participating in the study

- Is female and pregnant or lactating

- Positive results for the urine or saliva drug screen or urine or breath alcohol
screen at screening or check-in unless the positive drug screen is due to
prescription drug use that is approved by the Investigator and Sponsor

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

- Seated heart rate is equal to or lower than 44 beats per minute (bpm) or higher than
100 bpm at screening

- Has had a renal transplant or has had nephrectomy

- Donation of blood or had significant blood loss within 56 days prior to dosing of
study drug, or donation of plasma within 7 days prior to dosing

- Has participated in another clinical trial within 28 days prior to dosing of study
drug
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