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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

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.

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Detailed Description

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

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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BMS-754807 + Metformin

Group Type EXPERIMENTAL

BMS-754807 (IGR-IR/IR Inhibitor)

Intervention Type DRUG

Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17

Metformin

Intervention Type DRUG

Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily

Interventions

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BMS-754807 (IGR-IR/IR Inhibitor)

Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17

Intervention Type DRUG

Metformin

Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes