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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| darapladib | Experimental | darapladib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-480848 (darapladib) | Drug | 160 mg darapladib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events as reported by subjects. | From dosing through to follow-up visit. |
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Inclusion Criteria:
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG.
Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of:
Body weight >= 50 kg and BMI within the range 19 - 30 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | King of Prussia | Pennsylvania | 19406 | United States |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LPL111814 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529040 | darapladib |
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For additional information about this study please refer to the GSK Clinical Study Register |
| LPL111814 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL111814 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL111814 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL111814 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL111814 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |