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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00704431 |
Subjects will receive their first dose of darapladib in the clinical research unit (CRU), and the remaining 9 days of dosing will occur at home.
Subjects will record any adverse events throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days after the last dose of darapladib for a follow-up visit. The total study duration for each subject including the screening, treatment and follow-up periods will be approximately 4 weeks.
Condition | Intervention | Phase |
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Atherosclerosis |
Drug: SB-480848 (darapladib) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open Label, Single Session Study to Collect Tolerability Information Following Repeat Dosing of Darapladib in Healthy Adult Subjects |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female subject is eligible to participate if she is of:
Exclusion Criteria:
United States, Pennsylvania | |
GSK Clinical Trials Call Center | Recruiting |
King of Prussia, Pennsylvania, United States, 19406 | |
Contact: Yvonne Surh 877-379-3718 |
Study Director: | GSK Clinical Trials, M.D. | GlaxoSmithKline |
Study ID Numbers: | LPL111814 |
Study First Received: | June 20, 2008 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00704431 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SB-480848, darapladib, tolerability |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Healthy Arteriosclerosis |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Cardiovascular Diseases Arteriosclerosis |