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Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

NCT ID: NCT02475135

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2015-08-14

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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Immunodeficiency Virus Type 1, Human Immunodeficiency Virus Type 2, Human Darunavir Cobicistat Tenofovir Alafenamide Emtricitabine Elvitegravir

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel 1: Group 1

Subject will receive a single oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) (D/C/F/TAF) under fed conditions (standardized regular breakfast, test Panel 1) on Day 1 of treatment period 1 and by FDC of elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/ tenofovir alafenamide (TAF) (E/C/F/TAF) under fed conditions (standardized regular breakfast, reference Panel 1) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Standardized Regular Breakfast

Intervention Type OTHER

Standardized regular breakfast will administered.

Panel 1: Group 2

Subject will receive a single oral tablet of FDC containing E/C/F/TAF under fed conditions (standardized regular breakfast, reference Panel 1) on Day 1 of treatment period 1 and a single oral tablet of FDC containing D/C/F/TAF under fed conditions (standardized regular breakfast, test Panel 1) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Standardized Regular Breakfast

Intervention Type OTHER

Standardized regular breakfast will administered.

Panel 2: Group 1

Subject will receive a single oral tablet of D/C/F/TAF under fed conditions (standardized regular breakfast, test Panel 2) on Day 1 of treatment period 1 and a single oral tablet of DRV, a tablet of emtricitabine/ tenofovir alafenamide (FTC/TAF) and a tablet of COBI under fed conditions (standardized regular breakfast, reference Panel 2) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Darunavir

Intervention Type DRUG

A tablet containing Darunavir (DRV) 800 mg will be administered.

Emtricitabine/Tenofovir alafenamide (FTC/TAF)

Intervention Type DRUG

A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.

Cobicistat

Intervention Type DRUG

A tablet containing cobicistat (COBI) 150 mg will be administered.

Standardized Regular Breakfast

Intervention Type OTHER

Standardized regular breakfast will administered.

Panel 2: Group 2

Subject will receive a single oral tablet of DRV, a tablet of FTC/TAF and a tablet of COBI under fed conditions (standardized regular breakfast, reference Panel 2) on Day 1 of treatment period 2 and a single oral tablet of D/C/F/TAF under fed conditions (standardized regular breakfast, test Panel 2) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Darunavir

Intervention Type DRUG

A tablet containing Darunavir (DRV) 800 mg will be administered.

Emtricitabine/Tenofovir alafenamide (FTC/TAF)

Intervention Type DRUG

A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.

Cobicistat

Intervention Type DRUG

A tablet containing cobicistat (COBI) 150 mg will be administered.

Standardized Regular Breakfast

Intervention Type OTHER

Standardized regular breakfast will administered.

Panel 3: Group 1

Subject will receive a single oral tablet of D/C/F/TAF under fasted conditions (test Panel 3) on Day 1 of treatment period 1 and a single oral tablet of D/C/F/TAF with a standardized high-fat breakfast (reference Panel 3) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Panel 3: Group 2

Subject will receive a single oral tablet of D/C/F/TAF with a standardized high-fat breakfast (reference Panel 3) on Day 1 of treatment period 1 followed by a single oral tablet of D/C/F/TAF under fasted conditions (test Panel 3) on Day 1 of treatment period 2.

Group Type EXPERIMENTAL

Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

Intervention Type DRUG

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

High-fat Breakfast

Intervention Type OTHER

High-fat breakfast will be administered.

Interventions

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Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Intervention Type DRUG

Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC

A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.

Intervention Type DRUG

Darunavir

A tablet containing Darunavir (DRV) 800 mg will be administered.

Intervention Type DRUG

Emtricitabine/Tenofovir alafenamide (FTC/TAF)

A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.

Intervention Type DRUG

Cobicistat

A tablet containing cobicistat (COBI) 150 mg will be administered.

Intervention Type DRUG

High-fat Breakfast

High-fat breakfast will be administered.

Intervention Type OTHER

Standardized Regular Breakfast

Standardized regular breakfast will administered.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject must be a non-smoker for at least 3 months prior to selection
* Subject must have a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m\^2, extremes included

Exclusion Criteria

* Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol


* Subject has a positive human immunodeficiency virus-1 (HIV-1) or HIV-2 test at screening
* Subject 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
* Subject has currently significant and active diarrhea, nausea, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability
* Subject has any history of renal insufficiency
* Subject has known allergies, hypersensitivity, or intolerance to DRV, COBI (GS-9350), EVG (Panel 1 only), FTC, TAF or their excipients
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Sciences Ireland UC Clinical Trials

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

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Antwerp, , Belgium

Site Status

Countries

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Belgium

References

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Crauwels HM, Baugh B, Van Landuyt E, Vanveggel S, Hijzen A, Opsomer M. Bioequivalence of the Once-Daily Single-Tablet Regimen of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Compared to Combined Intake of the Separate Agents and the Effect of Food on Bioavailability. Clin Pharmacol Drug Dev. 2019 May;8(4):480-491. doi: 10.1002/cpdd.628. Epub 2018 Nov 9.

Reference Type DERIVED
PMID: 30412360 (View on PubMed)

Other Identifiers

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2015-001213-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TMC114FD2HTX1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR107430

Identifier Type: -

Identifier Source: org_study_id