The Pharmacokinetics of Gefapixant (MK-7264) in Participants With Renal Insufficiency (MK-7264-026)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: Gefapixant
Intervention description: After an overnight fast participants receive a single oral dose of 50 mg gefapixant, in one 50 mg tablet.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial aims to evaluate the plasma pharmacokinetics of gefapixant (MK-7264) administered
      to participants with varying degrees of renal insufficiency (RI) compared to healthy matched
      controls; and to investigate the extent of MK-7264 removal by hemodialysis (HD) in
      participants with end stage renal disease (ESRD), following administration of a single 50 mg
      dose of gefapixant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a non-smoker or moderate smoker (≤ 20 cigarettes/day or the equivalent) who agrees
             to consume no more than 10 cigarettes or equivalent/day from the time of screening and
             throughout the period of sample collection.

          -  Has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2,

          -  Is judged to be in good health based on medical history, physical examination, vital
             signs, and laboratory safety tests. Has no clinically significant electrocardiogram
             (ECG) abnormality, as deemed by the Investigator.

          -  Females are non-pregnant, and non-breast feeding. If female with reproductive
             potential, they must demonstrate they are not pregnant and agree to use (and/or have
             their partner use) two (2) acceptable methods of birth control beginning at screening,
             throughout the study and until 2 weeks after dosing of study drug.

          -  Participants with ESRD requiring HD has been maintained on stable regimen of
             thrice-weekly HD for at least 3 months prior to first dosing.

          -  Healthy participants, must be within ± 10 years of the mean age of participants with
             RI; and must be within ± 10 kg of the mean weight of participants with RI.

        Exclusion Criteria:

          -  Is mentally or legally incapacitated or has significant emotional problems at the time
             of the screening visit, or expected during the conduct of the study.

          -  Has a history or presence of clinically significant medical or psychiatric condition
             or disease.

          -  Has a 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.

          -  Has a history or presence of alcoholism or drug abuse within the past 6 months prior
             to dosing.

          -  Has a history or presence of hypersensitivity or idiosyncratic reaction to the study
             drug or related compounds (including sulfonamides).

          -  Has a history or presence of renal artery stenosis; or major risk factors for
             renal/urinary calculi.

          -  Has rapidly fluctuating renal function as determined by historical measurements.

          -  Female who is pregnant, or lactating.

          -  Has positive results for urine or saliva drug and/or urine or breath alcohol at
             screening or check-in.

          -  Is positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV).

          -  Has positive macroscopic hematuria or crystalluria at screening or check-in.

          -  Is unable to refrain from or anticipates using any medication or substance including
             prescription or over-the-counter, vitamin supplements, natural or herbal supplements.

          -  Has been on a diet incompatible with the on-study diet, within the 28 days prior to
             dosing.

          -  Has donated blood or had significant blood loss within 56 days prior to dosing.

          -  Has donated plasma within 7 days prior to dosing.

          -  Has taken gefapixant at any time prior to dosing on the current study.

          -  Has participated in another clinical trial within 28 days prior to dosing based on the
             latest blood collection or dosing.