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Completed

NCT Number: NCT01525823

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Melbourne, Victoria, 3004, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-754807 (IGR-IR/IR Inhibitor)

Drug

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

metformin

Drug

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

Primary outcomes

  1. 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

  1. Safety endpoints: AEs and marked clinical laboratory abnormalities

    Time frame: 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Plasma half-life (T-HALF) of BMS-754807 and M5

    Time frame: 12 timepoints over 72 hours for the Day 5 dose

  8. Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) 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

  9. Mean levels of plasma glucose, serum insulin and c-peptide

    Time frame: Day 3, Day 5 and Day 17

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects

Acronym: NHV

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2012
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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