TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa. Steady state is a term which 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. TMC278 and Tenofovir are two antiretroviral drugs for treatment of human deficiency virus (HIV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Detailed Description

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TMC435 is being investigated for treatment of chronic HCV infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). About 30% of all HIV infected patients are co-infected with HCV and need treatment for both infections. The results of this study will provide dosing recommendations for coadministration of TMC435 and TMC278 or Tenofovir in HCV-HCV co-infected patients. This is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (sequence of treatment with study medications is assigned by chance), crossover trial in 48 healthy participants to investigate the pharmacokinetic interaction between TMC435 and an antiretroviral agent (TMC278 or tenofovir), at steady state. The participants are being allocated to one of two panels. In Panel 1, participants will receive three treatments (treatment A-B-C) in a randomized order. Participants will receive TMC435 150 mg q.d., TMC278 25 mg q.d.and TMC278 25 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 11 days and with food. 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. In Panel 2, participants will receive three treatments (treatment D-E-F) in a randomized order. Participants will receive TMC435 150 mg q.d., TDF 300 mg q.d. and TDF 300 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 7 days and with food. There will be a washout period of at least 7 days. Pharmacokinetic profiles of all three 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 on days 1 and 11 and on Day 12 in each session of Panel 1, before medication intake on days 1 and 7 and on Day 8 in each session of Panel 2, 5 hours post dose on Day11 and Day 7 in Panel 1 and 2, respectively and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of study medication in the last session. A physical examination will be performed at screening, on day -1 (= day before first medication intake in each session for both panels) and during the 2 follow up visits. Each volunteer will receive 3 treatments for 11 or 7 days (Panel 1 and 2, respectively), minimum 14 or 7 days apart from each other (Panel 1 and 2, respectively). Volunteers in Panel 1 will take oral TMC435 150 mg q.d., oral TMC278 25 mg q.d. and combined. Volunteers in Panel 2 will take oral TMC435 150 mg q.d., oral TDF 300 mg q.d. and combined.

Conditions

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Hepatitis C Virus

Keywords

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TMC435-TiDP16-C114 TMC435-C114 TMC435 HCV Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

150 mg TMC435 capsule + 300 mg TDF tablet, once daily for 7 days

150 mg capsule once daily for 11 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No-smoker for at least 3 months
* Body Mass Index of 18.0 to 30.0 kg/m2
* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria

* Infection with Hepatitis A, B or C Virus
* Infection with the Human Immunodeficiency Virus (HIV)
* History of, or any current medical condition which could impact the safety of the participant in the study
* Having previously participated in a multiple-dose trial with TMC435 and/or TMC278, or in a single- or multiple-dose trial with TMC278 long-acting
* Having previously participated in more than 3 single-dose trials with TMC435 and/or TMC278.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec Pharmaceuticals Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceutical Limited

Countries

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Belgium

Other Identifiers

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CR017392

Identifier Type: -

Identifier Source: org_study_id

TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

001

TMC435

002

TMC278

003

TMC435 + TMC278

004

TMC435

005

TDF

006

TMC435 + TDF

Interventions

TMC435

TDF

TMC435 + TDF

TMC435 + TMC278

TMC278

TMC435

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Tibotec Pharmaceuticals, Ireland

Responsible Party

Principal Investigators

Tibotec Pharmaceuticals Clinical Trial

Countries

Other Identifiers

CR017392