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

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

Overview[ - collapse ][ - ]

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	Healthy Volunteers
Intervention	Drug: BMS-754807 (IGR-IR/IR Inhibitor) Drug: Metformin
Phase	Phase 1
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT01525823
First Received	January 18, 2012
Last Updated	June 13, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 18, 2012
Last Updated Date	June 13, 2012
Start Date	February 2012
Estimated Primary Completion Date	April 2012
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
Official Title	Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
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 Type	Interventional
Study Phase	Phase 1
Study Design	Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Condition	Healthy Volunteers
Intervention	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
Study Arm (s)	Experimental: BMS-754807 + Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	26
Estimated Completion Date	April 2012
Estimated Primary Completion Date	April 2012
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Australia

Administrative Information[ + expand ][ + ]

NCT Number	NCT01525823
Other Study ID Numbers	CA191-015
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Not Provided
Investigators	Study Director: Bristol_Myers Squibb Bristol-Myers Squibb
Verification Date	June 2012

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