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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Ciprofloxacin; Simeprevir

Criteria

Inclusion Criteria:

• Skin type I to III

• No ultraviolet exposure on the back for 4 weeks prior to baseline phototesting

• Normal skin response during baseline phototesting

• Body Mass Index of 18.0 to 30.0 kg/m2

• Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram.

Exclusion Criteria:

• History of hypersensitivity to sunlight or artificial source of intense light, especially UV light

• history or currently active porphyria or lupus erythematosus

• Positive plasma porphyrin scan and lupus erythematosus antibodies

• Active skin disorders on the back where phototesting will be performed

• Infection with Hepatitis A, B or C virus

• Infection with the human immunodeficiency virus (HIV)

• Women who are pregnant or breastfeeding

• History of or any current medical condition which could impact the safety of the participant in the study