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TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir

NCT01288755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-06-27

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

TMC278

One 25 mg tablet, once daily, for 11 days (TrtA and C)

DRUG

Raltegravir

One 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC)

Sponsors & Collaborators

  • Raltegravir is provided by Merck.

    collaborator UNKNOWN

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288755 on ClinicalTrials.gov