NCT01308658

Brief Summary

In this study participants will be given 800 mg darunavir, either as one 800-mg tablet formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

First QC Date

February 3, 2011

Last Update Submit

February 5, 2014

Conditions

Healthy

Keywords

TMC114-C176TMC114DRVHIVHealthy volunteers

Outcome Measures

Primary Outcomes (3)

  • Plasma concentrations of 100-mg ritonavir after a multiple oral dose on Days 1 to 5 in healthy volunteers in fed or fasted conditions

    measured on Day 1 to Day 6

  • Plasma concentrations of Darunavir (DRV) after a single oral dose of 800-mg DRV on Day 3 in healthy volunteers in fed or fasted conditions

    measured on Day 1

  • Plasma concentrations of DRV after a single oral dose of 800-mg DRV on Day 3 in healthy volunteers in fed or fasted conditions

    measured on Day 3 to Day 6

Secondary Outcomes (5)

  • Incidence of all adverse events by treatment group

    Measured from Day 1 until end of trial

  • Blood tests

    Measured from Day 1 until end of trial

  • Measurements of blood pressure

    Measured from Day 1 until end of trial

  • Measurements of pulse

    Measured from Day 1 until end of trial

  • Measurements of electrocardiograms

    Measured from Day 1 until end of trial

Study Arms (2)

001

EXPERIMENTAL

Darunavir (DRV) 2x400-mg DRV tablet or 800-mg tablet on Day 3

Drug: Darunavir (DRV)

002

EXPERIMENTAL

ritonavir 100-mg once daily on Day 1 to Day 5

Drug: ritonavir

Interventions

Darunavir (DRV)DRUG

2x400-mg DRV tablet or 800-mg tablet

001
ritonavirDRUG

on Day 3

002

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
  • Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months
  • Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study or have a vasectomized partner
  • Men must agree to use a highly effective method of birth control.

You may not qualify if:

  • Infection with Hepatitis A, B, or C virus
  • infection with HIV
  • Women who are pregnant or breastfeeding
  • History of, or any current medical condition which could impact the safety of the participant in the study
  • Previously participated in a multiple-dose study with DRV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

Related Publications (1)

  • Kakuda TN, Leopold L, Timmers M, Van De Casteele T, Hillewaert V, Tomaka FL, Hoetelmans RM. Bioavailability and bioequivalence of a darunavir 800-mg tablet formulation compared with the 400-mg tablet formulation. Int J Clin Pharmacol Ther. 2014 Sep;52(9):805-16. doi: 10.5414/cp202066.

    PMID: 25109510DERIVED

MeSH Terms

Interventions

DarunavirRitonavir

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    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

February 3, 2011

First Posted

March 4, 2011

Study Start

January 1, 2011

Study Completion

May 1, 2011

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

DE(1)