Healthy Volunteers
Conditions
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
Interventions
DRUGBMS-754807 (IGR-IR/IR Inhibitor)
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
DRUGMetformin
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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 | — |
| 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 | — |
Countries
Australia
Outcome results
None listed