The Pharmacokinetics of Gefapixant (MK-7264) in Participants With Renal Insufficiency (MK-7264-026)



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:9/21/2017
Start Date:April 14, 2017
End Date:September 13, 2017

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An Open-Label, Single-Dose Study to Investigate the Influence of Renal Insufficiency on the Pharmacokinetics of MK-7264

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 in participants
with end stage renal disease (ESRD), following administration of a single 50 mg dose of
gefapixant.


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/m2,

- 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.
We found this trial at
2
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
Phone: 407-472-0227
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Orlando, FL
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550 West 84 Street
Hialeah, Florida 33014
305-817-2900
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Hialeah, FL
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