Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of
      Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose
      combination (FDC) with darunavir (DRV) and cobicistat (COBI)
      (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) relative to
      administration as an FDC with Elvitegravir (EVG) and COBI
      (Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), under fed conditions in
      healthy subjects (Panel 1); evaluate the single-dose pharmacokinetics and relative
      bioavailability of DRV, COBI, FTC and TAF when administered as an FDC (D/C/F/TAF) or as
      separate agents (D+C+FTC/TAF), under fed conditions in healthy subjects (Panel 2) and to
      evaluate the impact of food (fasting or high-fat breakfast) on the single-dose
      pharmacokinetics of DRV, COBI, FTC, and TAF when administered as an FDC (D/C/F/TAF) in
      healthy subjects (Panel 3).
    

Detailed description: 
      This is a Phase 1, 3-panel, open-label, randomized, 2-way crossover study in healthy
      subjects. Healthy subjects will be divided over 3 panels (Panel 1, 2 and 3). Subjects will be
      randomized within each panel. In each panel, during 2 subsequent sessions, each subject will
      receive 2 treatments (Treatments A and B in Panel 1, Treatments C and D in Panel 2, and
      Treatments E and F in Panel 3). Each treatment is defined as follows: Treatment A: single
      oral dose of D/C/F/TAF 800/150/200/10 milligram (mg) as FDC tablet under fed conditions
      (standardized regular breakfast); Treatment B: single oral dose of E/C/F/TAF 150/150/200/10
      mg as FDC tablet under fed conditions; Treatment C: single oral dose of D/C/F/TAF
      800/150/200/10 mg as FDC tablet under fed conditions; Treatment D: single oral dose of DRV as
      800-mg tablet, FTC/TAF as 200/10 mg tablet and COBI 150 mg tablet under fed conditions.
      Treatment E: single oral dose of D/C/F/TAF 800/150/200/10 mg as FDC tablet, under fasted
      condition and Treatment F: single oral dose of D/C/F/TAF 800/150/200/10 mg tablet, with a
      standardized high-fat breakfast. Each treatment will be separated by a washout period of at
      least 7 days. Primarily pharmacokinetic parameters will be assessed. Subjects' safety will be
      assessed throughout.
    

Intervention name(s): Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC; Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC; Darunavir; Emtricitabine/Tenofovir alafenamide (FTC/TAF); Cobicistat; High-fat Breakfast; Standardized Regular Breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other; Other
Intervention description(s): A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.; A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.; A tablet containing Darunavir (DRV) 800 mg will be administered.; A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.; A tablet containing cobicistat (COBI) 150 mg will be administered.; High-fat breakfast will be administered.; Standardized regular breakfast will administered.
Intervention MeSH terms: Tenofovir; Emtricitabine; Darunavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Elvitegravir; Cobicistat mixture with darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunodeficiency Virus Type 1, Human; Immunodeficiency Virus Type 2, Human; Darunavir; Cobicistat; Tenofovir Alafenamide; Emtricitabine; Elvitegravir