A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: darunavir; Drug: cobicistat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01619527

TMC114IFD1003 (Other Identifier)

CR100699

2012-000273-23 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.

Full description

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants. The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs. The study consists of 3 panels. In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3). Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).

Enrollment: 133 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening
• Have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
• Men and women must agree to use a highly effective method of birth control

Exclusion criteria

• Has a positive HIV-1 or HIV-2 test at screening
• Has a Hepatitis A, B or C infection (confirmed by hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody, respectively) at screening
• Has any history of renal insufficiency
• Has a history of significant skin reactions or any history of allergies to drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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133 participants in 6 patient groups

Treatment A

Experimental group

Description:

Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fasted condition)

Treatment:

Drug: cobicistat

Drug: darunavir

Treatment B

Experimental group

Description:

Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fasted condition).

Treatment:

Drug: cobicistat

Drug: darunavir

Treatment C

Experimental group

Description:

Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fed condition - standardized breakfast).

Treatment:

Drug: cobicistat

Drug: darunavir

Treatment D

Experimental group

Description:

Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - standardized breakfast).

Treatment:

Drug: cobicistat

Drug: darunavir

Treatment E

Experimental group

Description:

Single-dose co-administration of the fixed dose combination darunavir/cobicistat 800/150-mg (under fasted condition).

Treatment:

Drug: cobicistat

Drug: darunavir

Treatment F

Experimental group

Description:

Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - high-fat breakfast).

Treatment:

Drug: cobicistat

Drug: darunavir