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This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albiglutide + moxifloxacin placebo | Active Comparator | Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40 |
|
| Albiglutide matching placebo + moxifloxacin | Active Comparator | Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albiglutide | Biological | once weekly subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval | Measurement of cardiac repolarization after albiglutide dosing | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval | Measurement of cardiac repolarization after albiglutide dosing | Day 4 |
| QT interval | Determination of the effect of moxifloxacin on cardiac repolarization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 |
|---|---|
| Results for study 107085 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107085 | Annotated Case Report Form | 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 |
|---|---|
| C534611 | rGLP-1 protein |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin |
| Drug |
oral tablet |
|
| Day -1 and Day 40 |
| Number of participants with adverse events | Number of participants with adverse events | 6 weeks |
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107085 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D004700 | Endocrine System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |