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

Bristol-Myers Squibb26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

BMS-754807 (IGR-IR/IR Inhibitor)DRUG

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

MetforminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration

Time frame: On Day 3 and Day 17

Secondary Outcomes

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

Time frame: Day -21 to Day 47

Maximum observed plasma concentration (Cmax) of BMS-754807 and M5

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose

Data from ClinicalTrials.gov

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