Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/8/2017 |
| Start Date: | December 15, 2016 |
| End Date: | February 8, 2017 |
A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Bioavailability of the Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Administered Orally as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Subjects
The purpose of this study is to evaluate the single-dose pharmacokinetics and relative
bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,
Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a
fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as
Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed
as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):
a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with
240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF
(800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.
bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg,
Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a
fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as
Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed
as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test):
a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with
240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF
(800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.
Inclusion Criteria:
- Non-smoker for at least 3 months prior to selection
- Body mass index (BMI) of 18.0 to 32 kilogram per square meter (kg/m^2), inclusive
- Woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin
[beta-hCG]) pregnancy test at screening and a negative sensitive urine pregnancy test
on Day -1 before the first dose of study drug
- Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for at least 90 days after receiving the last dose
of study drug
- During the study and for a minimum of 1 spermatogenesis cycle (defined as
approximately 90 days) after receiving the last dose of study drug, a
non-vasectomized man who is sexually active with a woman of childbearing potential
must agree to use a highly effective barrier method of contraception
Exclusion Criteria:
- Positive human immunodeficiency virus -1 (HIV-1) or HIV-2 test at screening
- Hepatitis A, B, or C infection, confirmed by a positive hepatitis A antibody
immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus
antibody (anti-HCV) test, respectively, at screening
- History of renal insufficiency
- History of significant drug-induced skin reactions (such as, but not limited, to
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and/or erythema
multiforme) or history of allergies to drugs (such as, but not limited to,
sulfonamides and penicillins)
- Previously participated in a multiple-dose study with Darunavir (DRV), Cobicistat
(COBI), Emtricitabine (FTC), Tenofovir Alafenamide (TAF), or Tenofovir Disoproxil
Fumarate (TDF)
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