TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients

Summary

The purpose of this study is to assess the safety and tolerability of TMC647055 both after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days and to assess the effect of food on a single oral dose of TMC647055 at one dose level, all in healthy participants. In addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055 will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10 days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C infection.

Conditions

• Hepatitis C

Interventions

DRUG

TMC647055

One single dose as oral solution, doses from 100 mg up to a maximum of 3000 mg increasing in sessions I through VI.

DRUG

Placebo

Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.

DRUG

TMC647055

Oral solution given in session XIII, treatment arm 1 during 10 days at a dose of 1000 mg every 12 hours.

DRUG

TMC647055

In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.

DRUG

Placebo

One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII

DRUG

TMC435

Oral capsule given in session XIII, in treatment arm 1 during 10 days and in treatment arm 2 during 6 days at a dose of 150 mg once daily.

DRUG

Placebo

One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII

DRUG

TMC647055

One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII

DRUG

Placebo

In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.

DRUG

TMC647055

Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland

  lead INDUSTRY

Principal Investigators

• Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-04-30

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• Belgium

Study Locations