TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC278 25 mg q.d. and Raltegravir 400 mg b.i.d.
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the effect of steady-state concentrations of raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug has been given long enough so that the plasma levels will remain at about the same level with each subsequent dose. TMC278 is being investigated for the treatment of human immunodeficiency virus (HIV) infection. Raltegravir is a commercially available antiretroviral drug for treatment of 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 P25-P50 for phase_1 hiv-infections
Started Feb 2011
Shorter than P25 for phase_1 hiv-infections
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
January 7, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 27, 2011
June 1, 2011
January 7, 2011
June 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in exposure to TMC278 following co-administration with raltegravir and vice versa
Measured on Days 5, 12, 13, 14, 15, and 16 (TrtC). Reference for exposure to raltegravir only (TrtB), measured on Days 1, 2, 3, and 4. Reference for exposure to TMC278 only (TrtA), measured on Days 1, 8, 9, 10, 11, and 12.
Secondary Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability - TMC278 and raltegravir.
97 to 99 days (until and including last safety follow-up visit)
Study Arms (2)
001
EXPERIMENTALTMC278 One 25 mg tablet once daily for 11 days (TrtA and C)
002
EXPERIMENTALRaltegravir One 400 mg tablet twice daily for 4 days (Trt B) and for 11 days (TrtC)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, based on physical examination, medical history, vital signs, ECG, blood biochemistry, hematology and urinalysis
- Body Mass Index of 18 to 30.0 kg/m2
- Non-smoking for at least 3 months prior to screening
- Women must be postmenopausal for at least 2 years, or be surgically sterile.
You may not qualify if:
- Infected with Hepatitis A, B, or C Virus
- Infected with human immunodeficiency virus (HIV)
- History of clinically relevant hearth rhythm disturbances
- Having previously participated in more than 1 study with raltegravir, TMC125, TMC120 and/or TMC278 or having developed rash, erythema or urticaria while participating in a trial with aforementioned compounds
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
Study Record Dates
First Submitted
January 7, 2011
First Posted
February 2, 2011
Study Start
February 1, 2011
Study Completion
May 1, 2011
Last Updated
June 27, 2011
Record last verified: 2011-06