TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      TMC278 is being investigated for treatment of HIV infection. Raltegravir is a commercially
      available HIV drug. The results of this study will provide dosing recommendations for
      coadministration of TMC278 and raltegravir in HIV-infected patients. This is a Phase I,
      open-label (both participant and investigator know the name of the medication given at a
      certain moment), randomized (sequence of treatment with study medications is assigned by
      chance), crossover trial in 24 healthy volunteers to investigate the pharmacokinetic
      interaction between TMC278 and raltegravir, at steady state. The study will consist of 3
      phases: a screening phase, an open-label treatment phase consisting of 2 treatment periods,
      and end-of-study or withdrawal assessments. The duration of participation in the study for an
      individual participant will be up to 3 months (including screening). All participants will be
      randomly assigned to 1 of 2 possible treatment sequences and receive the following 2
      treatments (Trt-s): TMC278 25 mg, once daily, alone for 11 days (TrtA), and raltegravir 400
      mg, twice daily, alone for 4 days immediately followed by coadministration of the same
      raltegravir dose plus TMC278 25 mg, once daily, for 11 days (TrtB+C). There will be a washout
      period (a period where no study drug will be taken in view of having all the medication
      eliminated from the body before starting a new treatment) of at least 14 days between last
      intake of study medication in one session and first intake of study medication in the
      subsequent session. Pharmacokinetic profiles of both compounds will be determined through
      blood samples taken at regular intervals during the study. Safety and tolerability will be
      assessed during the study period and in follow-up. Blood and urine samples, electrocardiogram
      (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, before
      medication intake in TrtA on Days 1, 11, and 12 (Day 12 is without ECG), in TrtB+C on Days 1,
      4, 5, 15, and 16 (Day 16 is without ECG) and at the 2 follow-up visits (but without ECG) at 1
      week and 4 weeks after last dose of study medication in the last session. A physical
      examination will be performed at screening, on Days 10 and 12 of TrtA, on Days 3, 14, and 16
      of TrtB+C, and at both follow-up visits. Healthy volunteers will stay overnight in the study
      center for 3 nights in TrtA and for 5 nights in TrtB+C. Each volunteer will receive in a
      randomized order 2 treatments, minimum 14 days apart from each other. TrtA is TMC278 25 mg,
      once daily, for 11 days. TrtB+C is raltegravir 400 mg, twice daily, alone for first 4 days
      (TrtB) followed by coadministration of 400 mg raltegravir, twice daily, and TMC278 25 mg,
      once daily, on Days 5 to 15 (TrtC).
    

Intervention name(s): TMC278; Raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): One 25 mg tablet, once daily, for 11 days (TrtA and C); One 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC)
Intervention MeSH terms: Raltegravir Potassium; Rilpivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC278-TiDP6-C153; TMC278-C153; TMC278; HIV