Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Renal Insufficiency
Intervention: MK-3682B
Intervention description: FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir.
Intervention MeSH terms: Uprifosbuvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of
      MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) +
      grazoprevir (MK-5172) + ruzasvir (MK-8408) in participants with moderate (Part 1) and severe
      (Part 2) renal insufficiency (RI) to plasma PK in healthy participants.
    

Eligibility criteria:

        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

          -  BMI ≥ 18 and ≤ 40.0 kg/m^2

          -  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/1.73m^2 and < 60 mL/min/1.73m^2, based on
             the Modification of Diet in Renal Disease (MDRD) equation at screening

          -  Severe RI: has baseline eGFR ≥ 15 mL/min/1.73m^2 and < 30 mL/min/1.73m^2, 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