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The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.
Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-754807 + Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 (IGR-IR/IR Inhibitor) | Drug | Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration | On Day 3 and Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: AEs and marked clinical laboratory abnormalities | Incidence of adverse events (AEs), AEs leading to discontinuation, serious adverse events (SAEs), and deaths occurring up to 30 days after the last dose of study medication and marked abnormalities of laboratory values | Day -21 to Day 47 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol_Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| C545990 | BMS 754807 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily |
|
| Maximum observed plasma concentration (Cmax) of BMS-754807 and M5 |
| 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose |
| Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5 | 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5 | 12 timepoints over 72 hours for the Day 5 dose |
| Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5 | 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose |
| Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5 | 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose |
| Plasma half-life (T-HALF) of BMS-754807 and M5 | 12 timepoints over 72 hours for the Day 5 dose |
| Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5 | 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose |
| Mean levels of plasma glucose, serum insulin and c-peptide | Day 3, Day 5 and Day 17 |