Status:
COMPLETED
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which...
Detailed Description
This is an open-label, 2-part single dose study: Part 1 will include participants with mild, moderate, and severe renal impairment (as well as healthy control participants), and Part 2 will include pa...
Eligibility Criteria
Inclusion
- Females of non-childbearing potential. Male participants with female partner(s) of child-bearing potential agree to use a medically acceptable method of contraception during the study and for 90 days after dosing. If partner is pregnant, males agree to use a condom; if partner is of child-bearing potential, partner must use additional birth control
- Male participants agree not to donate sperm from the first dose until 90 days after dosing
- Adequate venous access
- Renal Impaired Participants
- Liver function tests (serum alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) and serum bilirubin (total and direct) within upper limit of normal
- Panels A, B, and C: no clinically significant change in renal status at least 1 month prior to dosing and not currently or previously been on hemodialysis
- Panel E only: ESRD maintained on stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing
- Healthy Participants
- Age within ± 15 years of the mean age of participants with impaired renal function to which the healthy participant is matched
- Medically healthy as per medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory safety tests
- Blood urea nitrogen, liver function tests (ALT, AST, alkaline phosphatase \[ALP\]), and serum bilirubin (total and direct) within upper limit of normal.
Exclusion
- Mentally/legally incapacitated, or significant emotional problems or significant psychiatric disorder
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, respiratory, genitourinary or major neurological abnormalities or diseases
- History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Clinically significant history of cancer
- Smoker and/or has used nicotine or nicotine-containing products within 3 months prior to screening
- Female participants of childbearing potential, pregnant, or lactating
- Positive results for urine or saliva drug screen and/or urine or breath alcohol screen at screening or check-in
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Consumes more than 3 glasses of alcoholic beverages within 6 months of screening
- Consumes excessive amounts of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
- Major surgery, donated or lost 1 unit of blood within 4 weeks prior to screening, or donated plasma within 7 days prior to dosing in Part 1 or first dose in Part 2
- Renal Impaired Participants
- Panels A, B, and C: Failed renal transplant or has had nephrectomy
- Panels A, B, and C: Rapidly fluctuating renal function, as determined by historical measurements; or demonstrated/suspected renal artery stenosis
- Panel E only: Has required frequent emergent HD (≥3) within a year prior to first dosing
- Healthy Participants
- Renal transplant or nephrectomy
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03259087
Start Date
September 1 2017
End Date
February 9 2018
Last Update
April 19 2019
Active Locations (2)
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1
Clinical Pharmacology of Miami ( Site 0001)
Hialeah, Florida, United States, 33014
2
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States, 32809