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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525823
First received: January 18, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: BMS-754807 (IGR-IR/IR Inhibitor)
Drug: Metformin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety endpoints: AEs and marked clinical laboratory abnormalities [ Time Frame: Day -21 to Day 47 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of BMS-754807 and M5 [ Time Frame: 12 timepoints over 72 hours for the Day 5 dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean levels of plasma glucose, serum insulin and c-peptide [ Time Frame: Day 3, Day 5 and Day 17 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-754807 + Metformin Drug: BMS-754807 (IGR-IR/IR Inhibitor)
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
Drug: Metformin
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525823

Locations
Australia, Victoria
Local Institution
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol_Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01525823     History of Changes
Other Study ID Numbers: CA191-015
Study First Received: January 18, 2012
Last Updated: June 13, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014