Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Raltegravir
Intervention description: Raltegravir 600 mg tablet
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single
      1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male in good health

          -  Body mass index (BMI) between 18.5 and 32.0 kg/m^2

          -  Nonsmoker and has not used nicotine-containing products for over 3 months at the time
             of screening test.

        Exclusion Criteria:

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary, or
             neurological (including cerebrovascular stroke and epilepsy) abnormalities or diseases

          -  Significant emotional problem at the time of screening test or suspected to occur
             during the conduct of the study, or has a history of clinically significant
             psychiatric disorder within the last 5 years

          -  History of malignancy

          -  History of clinically significant allergies to multiple antigens or severe allergies
             (e.g., food, drug, and latex [natural rubber] allergies), or has had an anaphylactic
             reaction or significant intolerability (e.g., systemic allergic reaction) to
             prescription or non-prescription drugs or food

          -  Positive for hepatitis B virus surface antigen, hepatitis C virus antibodies,
             syphilis, or HIV antigen or antibody on the screening test

          -  Had surgery or donated or lost blood within 4 weeks prior to the screening test

          -  Participated in another study (clinical trial) within 4 months prior to the screening
             test

          -  Consumes greater than 3 glasses of alcoholic beverages (definition of 1 glass: 354 mL
             for beer, 118 mL for wine, 29.5 mL for distilled spirits) per day

          -  Consumes greater than 6 servings (definition of 1 serving: equivalent to 120 mg of
             caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day

          -  Regular user of cannabis, any illicit drugs, or has a history of drug or alcohol abuse
             within 2 years at the time of the screening test. Participants must have a negative
             predose urine drug screen

          -  Unable to consent to refrain from the consumption of citrus beverages and foods (e.g.,
             grapefruits) beginning 2 weeks prior to administration of the study drug until the end
             of post-study examination, and the consumption of all fruit beverages and foods for 24
             hours predose and after dosing

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or
             child) who is study site or Sponsor staff directly involved with this study.