A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants
Condition: Healthy
Intervention: Darunavir/Cobicistat
Intervention description: Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1.
Intervention MeSH terms: Darunavir; Cobicistat; Cobicistat mixture with darunavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir
      (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI
      fixed-dose combination tablet) in healthy Japanese adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be healthy on the basis of physical examination, medical history,
             vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This
             determination must be recorded in the participants source documents and initialed by
             the investigator

          -  A woman of childbearing potential must have a negative serum (beta-human chorionic
             gonadotropin [hCG]) at screening and urine pregnancy test at the time of admission to
             the study site, hospitalization, and must not breast feed from screening onwards

          -  Contraceptive use by men or women should be consistent with local regulations
             regarding the use of contraceptive methods for participant participating in clinical
             studies

          -  A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for a period of at least 30 days after intake of the
             study drug

          -  Nonsmoker or participant who habitually smokes no more than 10 cigarettes or
             equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6
             months before study drug administration

        Exclusion Criteria:

          -  Participant has a history of or current clinically significant medical illness
             including (but not limited to) cardiac arrhythmias or other cardiac disease,
             hematologic disease, coagulation disorders (including any abnormal bleeding or blood
             dyscrasias), lipid abnormalities, significant pulmonary disease, including
             bronchospastic respiratory disease, diabetes mellitus, liver or renal insufficiency
             (estimated creatinine clearance below 80 milliliter per minute [mL/min]); thyroid
             disease, neurologic or psychiatric disease, infection, significant cardiac, vascular,
             pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic,
             psychiatric, metabolic disturbances or any other illness that the investigator
             considers should exclude the participant or that could interfere with the
             interpretation of the study results

          -  Participant has a history of malignancy before screening (exceptions are squamous and
             basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,
             that is considered cured with minimal risk of recurrence)

          -  Participant has a history of or current clinically significant skin reactions (such as
             but not limited to Stevens-Johnson Syndrome [SJS], Toxic Epidermal Necrolysis (TEN),
             and/or erythema multiforme) or any history of allergies to drugs, such as, but not
             limited to, sulfonamides and penicillins

          -  Participant has been contraindicated DRV and COBI per local prescribing information

          -  Participant is a woman, who is pregnant, or breast-feeding, or planning to become
             pregnant while enrolled in this study