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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Metformin; Drug: BMS-754807 (IGR-IR/IR Inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525823

CA191-015

Details and patient eligibility

About

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.

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

BMS-754807 + Metformin

Experimental group

Treatment:

Drug: Metformin

Drug: BMS-754807 (IGR-IR/IR Inhibitor)