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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This is an open-label study to investigate the feasibility of administering exenatide by continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e. Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide infusion in Part A | Experimental | Subjects in Part A will receive exenatide as a subcutaneous infusion at a constant rate for 24 hours. |
|
| Exenatide infusion in Part B | Experimental | Subjects in Part B will receive exenatide with daily increases in the infusion rate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of interruptions or deviations from prescribed exenatide infusion in Part A | To investigate the feasibility of administering exenatide via continuous subcutaneous infusion | 2 days |
| Characterization of interruptions or deviations from prescribed exenatide infusion in Part B | To investigate the feasibility of administering exenatide via continuous subcutaneous infusion | 8 days |
| Infusion rate adjustments when nausea/vomiting occurs in Part B | To investigate the feasibility of administering exenatide via continuous subcutaneous infusion. Infusion rate adjustment will be done to achieve tolerable infusion rate when nausea/vomiting occurs | 8 days |
| Number of participants with adverse events (AEs) in Part A | AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety | 17 days |
| Number of participants with AEs in Part B | AEs will be collected from the Day -1 and until the follow-up contact. AE data will be collected to evaluate the ability to monitor and maintain acceptable safety | 23 days |
| Laboratory parameter assessment in Part A | Laboratory parameters include: hematology, clinical chemistry, and urinalysis | 17 days |
| Laboratory parameter assessment in Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile of exenatide in Part A | PK parameters include: area under concentration time curve from time 0 to 24 hours (AUC0 to24), maximum observed concentration from time 0 to 24 hours (Cmax0 to 24), and average concentration from time 0 to 24 hours (Cavg0 to 24) versus time | PK samples will be collected at pre-dose, and at 0.5, 1, 2, 4, 6, 10, 14, 24, and 26 hours post dose. |
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Inclusion Criteria
Exclusion Criteria
Criteria Based Upon Diagnostic Assessments
Other Criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Baltimore | Maryland | 21225 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26160357 | Derived | Vlasakakis G, Johnson SL, Lin J, Yao X, Gruenloh CJ, Chism JP, Nunez DJ. Pharmacokinetics and Tolerability of Exenatide Delivered by 7-Day Continuous Subcutaneous Infusion in Healthy Volunteers. Adv Ther. 2015 Jul;32(7):650-61. doi: 10.1007/s12325-015-0222-4. Epub 2015 Jul 10. |
| Label | URL |
|---|---|
| Results for study 200016 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200016 | Study Protocol | 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 |
|---|---|
| D009765 | Obesity |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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Laboratory parameters include: hematology, clinical chemistry, and urinalysis |
| 23 days |
| Vital sign assessment in Part A | Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate | 17 days |
| Vital sign assessment in Part B | Vital signs measurement include: systolic and diastolic blood pressure, and pulse rate | 23 days |
| Pharmacokinetic (PK) profile of exenatide in Part B | PK parameters include: AUC0-24, Cmax0 to 24, and Cavg0 to 24 versus time for each of 7 days and AUC0 to 168, Cmax0 to 168, and Cavg0 to 168 versus time over entire infusion period. | 8 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200016 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |