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

Sponsor

Tibotec Pharmaceuticals, Ireland (Industry)

Overall Status

Completed

CT.gov ID

NCT00752544

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HCV	Drug: TMC435350	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Phase I, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Ascending Oral Doses of TMC435350 After Single and Repeated Dosing in Healthy Japanese Male Subjects

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

Determine the short-term safety and tolerability of TMC435350 in healthy Japanese male volunteers after single and multiple doses and determine the plasma pharmacokinetics of TMC435350 after single and multiple doses. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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