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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS-754807 (IGR-IR/IR Inhibitor); Drug: Metformin

• Registration Number: NCT01525823
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2012-01-18
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-754807 + Metformin	BMS-754807 (IGR-IR/IR Inhibitor)	-
BMS-754807 + Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Plasma half-life (T-HALF) of BMS-754807 and M5	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
Safety endpoints: AEs and marked clinical laboratory abnormalities	Day -21 to Day 47	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
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
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

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Melbourne, Victoria, Australia