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This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warfarin plus albiglutide | Experimental | A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin plus albiglutide | Biological | A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45. |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide | 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR). | 52 days |
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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 | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23322139 | Background | Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613. | |
| 25387217 | Derived | Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836. |
| 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 |
|---|---|---|---|
| 111681 | Clinical Study Report | 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 |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C534611 | rGLP-1 protein |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Results for study 111681 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111681 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |