Clinical trial NCT01525823: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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

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

Primary outcomes:
measure: Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
timeFrame: On Day 3 and Day 17
Secondary outcomes:
measure: Safety endpoints: AEs and marked clinical laboratory abnormalities
timeFrame: Day -21 to Day 47
measure: Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
timeFrame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
measure: Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
timeFrame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5
timeFrame: 12 timepoints over 72 hours for the Day 5 dose
measure: Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5
timeFrame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
measure: Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5
timeFrame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
measure: Plasma half-life (T-HALF) of BMS-754807 and M5
timeFrame: 12 timepoints over 72 hours for the Day 5 dose
measure: Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5
timeFrame: 9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
measure: Mean levels of plasma glucose, serum insulin and c-peptide
timeFrame: Day 3, Day 5 and Day 17
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol_Myers Squibb
role: STUDY_DIRECTOR
References: