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 1 Completed 30 enrolled Tibotec Pharmaceuticals, Ireland

RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start: 2008-08
Primary completion: 2008-11
Completion: 2008-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simeprevir	Small molecule	100 mg	Oral
Subject	Simeprevir	Small molecule	200 mg	Oral
Subject	Simeprevir	Small molecule	400 mg	Oral

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

Summary

Timeline

Drugs

Indications