NCT00752544

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tibotec Pharmaceuticals, Ireland · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	TMC435350

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2008-09-15
• Last updated: 2010-04-28