A Study Evaluating the Pharmacokinetics of Doravirine in Participants With Severe Renal Impairment (MK-1439-051)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:January 2016
End Date:May 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-1439 (Doravirine) in Subjects With Severe Renal Impairment

This study will evaluate the effect of severe renal impairment on the pharmacokinetics of
doravirine.


Inclusion Criteria:

Participants with renal impairment:

- is a non-smoker or moderate smoker

- has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2

- other than renal impairment, participant is judged to be in good health based on
medical history, physical examination, vital signs, and laboratory safety tests

- female informed of the risks of pregnancy, agree not to become pregnant while
participating in this study. Female of childbearing potential must either be sexually
inactive for 14 days prior to dosing and throughout the study, or uses one acceptable
birth control method

- female of non-childbearing potential must have undergone sterilization procedures at
least 6 months prior to dosing.

- has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

Participants with renal impairment:

- is mentally or legally incapacitated or has significant emotional problems

- has a history or presence of clinically significant medical or psychiatric condition
or disease

- has history or presence of alcoholism or drug abuse within the past 2 years

- has history or presence of hypersensitivity or idiosyncratic reaction to the study
drug, any inactive ingredients, or related compounds

- has history or presence of renal artery stenosis

- has had a renal transplant or nephrectomy

- has rapidly fluctuating renal function as determined by historical measurements

- female is pregnant or lactating

- has positive results for the urine or saliva drug and urine or breath alcohol screen
at screening or check-in

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

- is unable to refrain from or anticipates the use of any drug, including prescription
and non-prescription medications, herbal remedies, or vitamin supplements beginning
14 days prior to dosing and throughout the study. Certain medications including those
to treat kidney disease will be permitted. Other medications may be permitted
following consultation with the Sponsor Clinical Monitor.

- is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A
(CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior
to dosing and throughout the study.

- has been on a diet incompatible with the on-study diet, within 28 days prior to
dosing, and throughout the study

- has donated blood or had significant blood loss within 56 days prior to dosing

- has donated plasma within 7 days prior to dosing

- has participated in another clinical trial within 28 days prior to dosing
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