drugset / Trial / NCT01124799

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

NCT01124799

Phase 1 Completed 49 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of the skin towards exposure to sunlight. TMC435 is a drug that is currently under development for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and tolerability of TMC435.

Timeline

Start
2010-07
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 500 mg Oral
Subject Simeprevir Small molecule Oral