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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00688272 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Subjects |
Drug: Ciprofloxacin Drug: Eltrombopag |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety Study |
| Official Title: | A Phase I, Double-Blind, Placebo and Observer-Blind Positive Controlled, Randomized, Parallel Group Study in Healthy Subjects to Investigate the Photoirritant Potential of Eltrombopag |
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | July 2008 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| United Kingdom, Forfarshire | |
| GSK Investigational Site | Recruiting |
| Dundee, Forfarshire, United Kingdom, DD1 9SY | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | TRA106914 |
| Study First Received: | May 28, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00688272 History of Changes |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
Safety Photoirritant Photosensitivity |
Placebo control Ciprofloxacin Eltrombopag |
|
Anti-Infective Agents Ciprofloxacin Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |