Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Islatravir
Intervention description: Single oral dose of 60 mg Islatravir administered in capsule form
Intervention MeSH terms: Islatravir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.