NCT01619527

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

June 12, 2012

Last Update Submit

March 1, 2013

Conditions

Healthy Participants

Keywords

Healthy participantsDarunavirCobicistatBioequivalenceFixed dose combinationPharmacokineticsHuman immunodeficiency virusProtease inhibitor

Outcome Measures

Primary Outcomes (4)

  • 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)

    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).

    Up to 27 Days

  • 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)

    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).

    Up to 27 Days

  • 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)

    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.

    Up to 27 Days

  • 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)

    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).

    Up to 27 Days

Secondary Outcomes (6)

  • Number of participants with adverse events as a measure of safety and tolerabilty

    Up to 27 Days

  • Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet

    Up to 27 Days

  • Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents

    Up to 27 Days

  • Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet

    Up to 27 Days

  • Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents

    Up to 27 Days

  • +1 more secondary outcomes

Study Arms (6)

Treatment A

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Treatment B

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Treatment C

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Treatment D

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Treatment E

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Treatment F

EXPERIMENTAL

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

Drug: darunavirDrug: cobicistat

Interventions

darunavirDRUG

Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat

Treatment ATreatment BTreatment CTreatment DTreatment ETreatment F
cobicistatDRUG

Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir

Treatment ATreatment BTreatment CTreatment DTreatment ETreatment F

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

DarunavirCobicistat

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Study Officials

  • Janssen R&D Ireland Clinical Trial

    Janssen R&D Ireland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

BE(1)