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TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

NCT01323257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-10-11

No results posted yet for this study

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r (Panel 2). Steady state is a term that 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. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

erythromycin

500 mg tablets three times a day for 6 days + 1 morning dose for 7th day (Trt B)

DRUG

Ritonavir

100 mg tablet once daily for 7 days (Trt E, F)

DRUG

TMC435

150 mg capsule once daily for 7 days (Trt A, C, D)

DRUG

Darunavir

2 x 400 mg tablet once daily for 7 days (Trt E, F)

DRUG

TMC435

50 mg capsule once daily for 7 days (Trt F)

DRUG

erythromycin

500 mg tablets three times a day for 7 days (Trt C)

Sponsors & Collaborators

  • 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
2011-03-31
Completion
2011-08-31

Countries

  • Belgium

Study Locations

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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 NCT01323257 on ClinicalTrials.gov