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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 Purpura, Thrombocytopenic, Idiopathic |
Drug: Ciprofloxacin Drug: Eltrombopag Drug: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 36 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Eltrombopag 75 mg QD x 6 days
|
Drug: Eltrombopag
Given QD x 6 days
Other Names:
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Active Comparator: Arm 2
Ciprofloxicin 500mg BID x 6 days
|
Drug: Ciprofloxacin
Given 500mg BID x 6 days
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Placebo Comparator: Arm 3
Placebo QD x 6 days
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Drug: Placebo
Given QD x 6 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects who had an clinically significant skin/allergic disease, including photo-allergy (excluding non
Contacts and Locations
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00688272 History of Changes |
| Other Study ID Numbers: | TRA106914 |
| Study First Received: | May 28, 2008 |
| Last Updated: | August 11, 2011 |
| Health Authority: | European Union: European Medicines Agency; United States: Food and Drug Administration |
|
Safety Photoirritant Photosensitivity |
Placebo control Ciprofloxacin Eltrombopag |
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Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia |
Blood Platelet Disorders Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Ciprofloxacin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |