Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
Status:
Completed
Trial end date:
2008-09-25
Target enrollment:
Participant gender:
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.