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

• Status: Completed
• Trial end date: 2020-10-19
• Target enrollment: 0
• Participant gender: All

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 good health.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: 4'-ethynyl-2-fluoro-2'-deoxyadenosine; Islatravir

Criteria

Inclusion Criteria:

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 Criteria:

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.