The Pharmacokinetics of MK-5172 and MK-8742 in Participants With Renal Insufficiency (MK-5172-050-00)
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 11/30/2013 |
Start Date: | September 2013 |
End Date: | January 2014 |
Contact: | Central Contact Toll Free Number |
Phone: | 1-888-577-8839 |
An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency
MK-5172 and MK-8742 are being studied as the principal components of combination oral
therapy for hepatitis C virus (HCV).
The study will examine the pharmacokinetic (PK) profiles of MK-5172 and MK-8742 following 10
days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or
severe renal impairment. Both groups will be compared to healthy matched controls.
Inclusion Criteria:
All Participants
- For a female of childbearing potential: either be sexually inactive (abstinent) for
14 days prior to the first dose and throughout the study or be using an acceptable
birth control method. Females of non-childbearing potential must have undergone a
sterilization procedure at least 6 months prior to the first dose
- Non-vasectomized male participants must agree to use a condom with spermicide or
abstain from sexual intercourse during the trial and for 90 days after stopping the
study medication and agree not to donate sperm during this time period Participants
with ESRD on HD
- Maintained on a stable regimen of HD within 3 months prior to first dosing
Participants with Severe Renal Impairment
- Estimated glomerular filtration rate (eGFR) at screening is < 30 mL/min/1.73m^2
Healthy Controls
- Participant is within ± 10 years of the mean age and within 10% of the mean body mass
index of severe renal impairment participants
- eGFR at screening is >=80 mL/min/1.73m^2
Exclusion Criteria:
All Participants
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic, or
neurological disease whose current condition is considered unstable
- History or presence of alcoholism and drug abuse within the past 6 months
- Female participants who are pregnant or lactating
- Regular user of any medication (including over the counter) that would significantly
alter GFR
- Donation of blood or significant blood loss within 56 days prior to the first dose of
study medication(s)
- Plasma donation within 7 days prior to the first dose of study medication(s)
- A renal transplant or nephrectomy Participants with ESRD or Severe Renal
Insufficiency
- Rapidly fluctuating renal function
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