Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

Completed · Phase 1

Conditions studied: Human Immunodeficiency Virus (HIV) Infection

In brief

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 good health.

Key facts

Study ID

NCT04303156

Run by

Merck Sharp & Dohme LLC

People needed

12

Starts

2020-06-18

Expected to finish

2020-10-19

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Pharmacology of Miami ( Site 0001) — Miami, Florida, United States
• Charite Research Organisation GmbH ( Site 0003) — Berlin, Germany

Full record on ClinicalTrials.gov

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