the pharmacokinetics of gefapixant (mk-7264) in participants with renal insufficiency (mk-7264-026)

Conditions: Renal Insufficiency

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.