Tibotec to study Protease Inhibitor TMC435 Photosensitivity in Healthy Volunteers

According to Clinical Trials.gov, Tibotec has plans to randomize 36 healthy volunteers to 75mg and 100mg QD of TMC435, or TMC435 placebo, or ciprofloxacin (500 mg BID) for  a total of 9 days.

Phototesting will be done  3 days before start of study medication starts and 3 days (Days 8, 9 and 10) during treatment.  Investigators will assess skin reactions, general tolerability and safety of TMC435 throughout the trial period (or longer if needed). Blood and urine samples will be taken at screening, on day 1, day 7, day 10 and at 2 follow-up visits. Plasma levels of TMC435 and ciprofloxacin will be determined on Day 1, 5, 6, 7 (16 times), 8 (twice), 9 (twice) and 10. ECG and vital signs will be taken at screening, on day 1, twice on day 7, on day 10 and at 2 follow-up visits. A physical examination will be done at screening, on day 1, day 10 and at both follow-up visits. This is planned to start shortly and is estimated to be completed in November 2010