AIDS prevention HIV infection
Conditions
Interventions
Treatment Sequence (AB), experimental:
Participant will receive a single oral tablet of darunavir (DRV) 800 milligram
(mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/
tenofovir alafenamid
Sponsors
Janssen Sciences Ireland UC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria:;- Participant must be nonsmoker for at least 3 months prior to selection - Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12lead electrocardiogram (ECG) performed at Screening. If the results are outside the normal reference ranges, the participant may be included only if they are not listed under the exclusion criteria and if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed/signed by the Investigator. - Participant must have a body mass index (BMI), between 18.5 and 30 kilogram per square meter (kg/m^2) (inclusive) - Participant must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the biochemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the abnormalities or deviations from normal are not listed in the exclusion criteria, and the Investigator judges they are not clinically significant. This determination must be recorded in the participant's source documents and initialed/signed by the Investigator - All female participants, except when postmenopausal, must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening and must not breastfeed from Screening onwards
Exclusion criteria
Exclusion criteria: Exclusion Criteria:;- Participant has a positive human immunodeficiency virus type (HIV1) or human immunodeficiency virus type 2 (HIV2) test at Screening. - Participant has hepatitis A, B, or C infection (confirmed by a positive hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen, and/or hepatitis C virus antibody, respectively) at Screening. - Participant has currently significant and active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, neoplastic, or infectious disease. Currently active dermatological disease that would interfere with a correct assessment of possible skin reactions to the study drugs. - Participant has currently significant and active diarrhea, nausea, or constipation that in the Investigator*s opinion could influence drug absorption or bioavailability. - Participant has any history of renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is: to evaluate the single-dose pharmacokinetics and pivotal bioequivalence of DRV 800 mg, FTC 200 mg, and TAF 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10 mg FDC) in the presence of 150 mg COBI, under fed conditions, in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: to evaluate the single-dose pharmacokinetics and relative oral bioavailability of COBI 150 mg when administered as FDC (D/C/F/TAF) relative to the 150-mg tablet formulation, in the presence of DRV 800 mg, FTC 200 mg, and TAF 10 mg, under fed conditions, in healthy subjects; * to evaluate the short-term safety and tolerability of coadministration of DRV 800 mg, COBI 150 mg, FTC 200 mg, and TAF 10 mg, under fed conditions, in healthy subjects. | — |
Countries
Netherlands
Outcome results
None listed