TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers

NCT ID: NCT00752544

Last Updated: 2010-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-11-30

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of three different doses of TMC435350 compared to placebo in healthy Japanese males.

Detailed Description

This is a Phase I, double-blind (neither the physician or the volunteer knows the dose of the study medication), randomized (study medication assigned by chance), placebo-controlled (dose without the study medication present) trial to determine the safety, tolerability and plasma pharmacokinetics (amount of medication in the blood) of TMC435350 after single and multiple oral doses in healthy male Japanese volunteers. 100 mg, 200 mg and 400 mg doses will be given as an oral solution. Six (6) doses will be given with a 3 day follow-up between the first and second dose. Additional follow-up will be done for 3 days after the last dose and at approximately 2 and 4 weeks after the last dose.

Conditions

HCV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

TMC435350

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy Japanese male volunteers between the ages of 20 and 55 years
• Japanese healthy volunteers who have resided outside of Japan for no more than five years and whose parents and maternal and paternal grandparents are Japanese
• Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
• Normal weight as defined by a Body Mass Index (BMI: weight in kg divided by square of height in meters) of 18.0 to 30.0 kg/m2
• Body weight above 50 kg at screening
• Informed Consent Form (ICF) signed voluntarily before any trial-related activity
• Normal 12-lead electrocardiogram (ECG) at screening
• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality.

Exclusion Criteria

• Healthy volunteers must not have any of the following characteristics: Past history of heart arrhythmias (extrasystoli, tachycardia at rest) or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, hypomagnesemia, family history of long QT Syndrome) or echographically suspected cardiomyopathy
• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use which in the investigator's opinion would compromise healthy volunteer's safety and/or compliance with the trial procedures
• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) or human immunodeficiency virus - type 1 (HIV-1) or HIV-2 infection at screening
• A positive urine drug test at screening. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids
• Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
• Any history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria
• History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy
• Use of concomitant medication, including herbal medications and dietary supplements and products containing Hypericum perforatum (e.g. St. John's wort), except for paracetamol (acetaminophen) or ibuprofen in a period of 14 days before the first trial medication intake
• Participation in another investigational drug trial within 30 days prior to the first intake of trial medication
• Donation of blood or plasma within 60 days preceding the first intake of trial medication

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role: lead

Principal Investigators

Tibotec Pharmaceuticals Limited Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceutical Limited

Other Identifiers

CR015418

Identifier Type: -

Identifier Source: org_study_id