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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-05-06

No results posted yet for this study

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.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

TMC435

one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days

DRUG

Placebo

placebo dose in the morning, at noon and in the evening, for 9 days

DRUG

Ciprofloxacin

one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-04-30
Completion
2011-04-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124799 on ClinicalTrials.gov