TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir
A Phase I, 2-panel, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Antiretroviral Agents, Efavirenz and Raltegravir, at Steady State
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of efavirenz or raltegravir , 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. Efavirenz and raltegravir 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 Oct 2010
Shorter than P25 for phase_1
1 active site
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
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedNovember 8, 2012
November 1, 2012
6 months
October 21, 2010
November 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Absorption of TMC435 following co-administration with efavirenz, and vice versa.
Measured on Day1, 12, 13, 14, 15, 16, 17 and 18 for both drugs in eaach treatment in Panel 1.
Absorption of TMC435 following co-administration with raltegravir, and vice versa.
Measured on Day1, 5, 6, and 7 for both drugs in each treatment of Panel2 and on Day8-11 for TMC435 only in treatment D and F in Panel 2.
Secondary Outcomes (2)
Number of participants with Adverse Events as a measure of Safety and Tolerability - TMC435 and efavirenz.
98 to 103 days (till and including last safety follow-up visit) for Panel 1
Number of participants with Adverse Events as a measure of Safety and Tolerability - TMC435 and raltegravir.
63 to 68 days (till and including last safety follow-up visit) for Panel 2
Study Arms (6)
001
EXPERIMENTALTMC435 Two 75 mg capsules once daily for 14 days
002
EXPERIMENTALefavirenz One 600 mg tablet once daily for 14 days
003
EXPERIMENTALTMC435 + efavirenz Two 75 mg TMC435 capsules + one 600 mg TMC278 tablet once daily for 14 days
004
EXPERIMENTALTMC435 Two 75 mg capsules once daily for 7 days
005
EXPERIMENTALraltegravir One 400 mg tablet twice daily for 7 days
006
EXPERIMENTALTMC435 + raltegravir Two 75 mg TMC435 capsules once daily and one 400 mg raltegravir tablet for 7 days
Interventions
Two 75 mg TMC435 capsules once daily and one 400 mg raltegravir tablet for 7 days
Two 75 mg TMC435 capsules + one 600 mg TMC278 tablet, once daily for 14 days
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
- Having previously participated in more than 3 single-dose trials with TMC435.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Berlin, Germany
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
October 21, 2010
First Posted
November 16, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
November 8, 2012
Record last verified: 2012-11