Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag

Summary

This study is designed to investigate the safety profile and the photoirritant potential of eltrombopag in healthy subjects. The study is placebo- and positive controlled, randomized, parallel group with three treatment arms: eltrombopag (75 mg QD), placebo, and a positive control (ciprofloxacin, 500 mg BID). Eltrombopag will be administered in a double-blind fashion with respect to placebo and the positive control, ciprofloxacin, will be administered under observer-blinded conditions. Twelve to fifteen subjects will be recruited into each arm, to assure total enrollment of 36 evaluable subjects. The primary endpoint is the photosensitizing potential of eltrombopag as measured by photoirritant index (PI) and change in minimum erythemal dose (MED) in comparison with placebo.

Timeline

Start

2008-06-02

Primary completion

2008-09-25

Completion

2008-09-25

Publications

• Background Bowen CJ, Lobb KM, Park JW, Sanderson B, Ferguson J. Eltrombopag (75 mg) does not induce photosensitivity: results of a clinical pharmacology trial. Photodermatol Photoimmunol Photomed. 2010 Oct;26(5):243-9. doi: 10.1111/j.1600-0781.2010.00538.x.

Drugs

Indications