A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
This study has been completed.
Sponsor:
Janssen R&D Ireland
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01619527
First received: June 12, 2012
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Participants |
Drug: darunavir Drug: cobicistat |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Janssen R&D Ireland:
Primary Outcome Measures:
- Comparison of maximum plasma analyte concentration (Cmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]The pharmacokinetic parameter (Cmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
- Comparison of last observed measurable analyte concentration (Clast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]The pharmacokinetic parameter (Clast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
- Comparison of actual sampling time to reach the maximum plasma analyte concentration (tmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]The pharmacokinetic parameter (tmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) for assessment of bioequivalance.
- Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration (AUClast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]The pharmacokinetic parameter (AUClast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
Secondary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerabilty [ Time Frame: Up to 27 Days ] [ Designated as safety issue: Yes ]Safety and tolerability of darunavir/cobicistat co-administration in healthy participants will be assessed by number of participants with adverse events.
- Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fed conditions in healthy participants will be evaluated.
- Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fed conditions in healthy participants will be evaluated.
- Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fasted conditions in healthy participants will be evaluated.
- Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fasted conditions in healthy participants will be evaluated
- Evaluation of effect of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state [ Time Frame: Up to 27 Days ] [ Designated as safety issue: No ]Effects of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state will be evaluated.
| Enrollment: | 133 |
| Study Start Date: | April 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment A
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fasted condition)
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
|
Experimental: Treatment B
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fasted condition).
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
|
Experimental: Treatment C
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fed condition - standardized breakfast).
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
|
Experimental: Treatment D
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - standardized breakfast).
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
|
Experimental: Treatment E
Single-dose co-administration of the fixed dose combination darunavir/cobicistat 800/150-mg (under fasted condition).
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
|
Experimental: Treatment F
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - high-fat breakfast).
|
Drug: darunavir
Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
Drug: cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
|
Detailed 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).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Janssen R&D Ireland |
| ClinicalTrials.gov Identifier: | NCT01619527 History of Changes |
| Other Study ID Numbers: | CR100699, TMC114IFD1003, 2012-000273-23 |
| Study First Received: | June 12, 2012 |
| Last Updated: | March 1, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products United States: Food and Drug Administration |
Keywords provided by Janssen R&D Ireland:
|
Healthy participants Darunavir Cobicistat Bioequivalence |
Fixed dose combination Pharmacokinetics Human immunodeficiency virus Protease inhibitor |
Additional relevant MeSH terms:
|
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013