TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir
A Phase I, 2-panel, Open-label, Randomized, Cross-over Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Antiretroviral Agents, TMC278 and Tenofovir Disoproxil Fumarate (TDF), at Steady State
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. TMC278 and Tenofovir are two antiretroviral drugs for treatment of human deficiency virus (HIV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 20, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedNovember 27, 2012
November 1, 2012
4 months
September 16, 2010
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate and extent of absorption of TMC435 following co-administration with TMC278 under fed condition, and vice versa.
Measured on Day1, 9, 10, 11 and 12 per treatment in Panel 1.
Rate and extent of absorption of TMC435 following co-administration with TDF under fed condition, and vice versa.
Measured on Day1, 5, 6, 7 and 8 per treatment in Panel 2.
Secondary Outcomes (2)
Safety and tolerability following co-administration of TMC435 and TMC278 (Panel 1)
89 to 94 days (till and including last safety follow-up visit) for Panel 1
Safety and tolerability following co-administration of TMC435 and TDF (Panel 2)
63 to 68 days (till and including last safety follow-up visit) for Panel 2
Study Arms (6)
001
EXPERIMENTALTMC435 150 mg capsule once daily for 11 days
002
EXPERIMENTALTMC278 25 mg tablet once daily for 11 days
003
EXPERIMENTALTMC435 + TMC278 150 mg TMC435 capsule + 25 mg TMC278 tablet once daily for 11 days
004
EXPERIMENTALTMC435 150 mg capsule once daily for 7 days
005
EXPERIMENTALTDF 300 mg tablet once daily for 7 days
006
EXPERIMENTALTMC435 + TDF 150 mg TMC435 capsule + 300 mg TDF tablet once daily for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- No-smoker for at least 3 months
- Body Mass Index of 18.0 to 30.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
You may not qualify if:
- Infection with Hepatitis A, B or C Virus
- Infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- Having previously participated in a multiple-dose trial with TMC435 and/or TMC278, or in a single- or multiple-dose trial with TMC278 long-acting
- Having previously participated in more than 3 single-dose trials with TMC435 and/or TMC278.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
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
September 16, 2010
First Posted
September 20, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
November 27, 2012
Record last verified: 2012-11