drugset / Trial / NCT01288755
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
Phase 1
Completed
24 enrolled
Tibotec Pharmaceuticals, Ireland
Raltegravir is provided by Merck. · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2011-02
- Primary completion
- —
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | 400 mg | — |
| Subject | Rilpivirine | Small molecule | 25 mg | — |