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This study is designed to assess the pharmacokinetics of darapladib and its metabolites following single and 28 days of repeat dosing of darapladib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental | single oral dose |
|
| Repeat Dose | Experimental | 28 day repeat dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darapladib | Drug | experimental drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary PK endpoints will include AUC and Cmax of darapladib and its metabolites (M10, M3 and M4) following single and repeat oral doses. Metabolite to parent AUC and Cmax ratio for each metabolite will be calculated as data permit. | following single and 28 day repeat dose | |
| Clinical safety data (spontaneous AE reporting, vital signs, nursing/physician observation, and clinical laboratory tests) will be the primary safety endpoint. | throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary PK endpoints will include Tmax and T½ of darapladib and its metabolites (M10, M3 and M4) as data permit. | following single and 28 day repeat dose | |
| Plasma Lp-PLA2 activity, expressed in terms of percent inhibition relative to baseline, as data permit. |
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Inclusion Criteria:
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 | Tacoma | Washington | 98418 | 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 |
|---|---|---|---|
| LPL112498 | 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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| following single and repeat dose |
For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL112498 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |