Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds

Official Title
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Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-754807 (IGR-IR/IR Inhibitor)
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory Women who are not of childbearing potential Exclusion Criteria: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations consistent with a healthy volunteer target population History of clinically relevant hypoglycemic events History of clinically relevant hyperglycemic events

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-754807 + Metformin<br> | Drug: BMS-754807 (IGR-IR/IR Inhibitor)<br>* Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17<br>Drug: Metformin<br>* Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |