Status:
COMPLETED
Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus (HIV) Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in ...
Eligibility Criteria
Inclusion
- Healthy participants must have the following:
- Is in good health
- Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
- Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
- Renally impaired participants must have the following:
- With the exception of renal impairment, is in generally good health
- Has a BMI ≥ 18.5 and ≤ 40 kg/m2
- Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
Exclusion
- Healthy participants must have the following:
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Is mentally or legally incapacitated, has significant emotional problems
- Has known hypersensitivity to the active substance or any of the excipients of the study drug
- Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
- Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within prior 4 weeks
- Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease
- Has participated in another investigational study within prior 4 weeks
- Other exclusions for healthy participants:
- Does not agree to follow the smoking restrictions
- Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day
- Consumes excessive amounts,of caffeinated beverages per day.
- Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months.
- Renally impaired participants must have the following:
- Has a history or presence of renal artery stenosis.
- Has had a renal transplant or nephrectomy.
- Has rapidly fluctuating renal function as determined by historical measurements.
- Has known hypersensitivity to the active substance or any of the excipients of the study drug.
- Has a history of cancer (malignancy).
- Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
- Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
- Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit.
- Other exclusions for renally impaired participants
- Does not agree to follow the smoking restrictions.
- Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day.
- Consumes excessive amounts of caffeinated beverages per day.
- Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04303156
Start Date
June 18 2020
End Date
October 19 2020
Last Update
October 28 2021
Active Locations (2)
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1
Clinical Pharmacology of Miami ( Site 0001)
Miami, Florida, United States, 33014
2
Charite Research Organisation GmbH ( Site 0003)
Berlin, Germany, 10117