Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
NHV
Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Feb 2012
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 14, 2012
June 1, 2012
2 months
January 18, 2012
June 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Safety endpoints: AEs and marked clinical laboratory abnormalities
Day -21 to Day 47
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
- +4 more secondary outcomes
Study Arms (1)
BMS-754807 + Metformin
EXPERIMENTALInterventions
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Melbourne, Victoria, 3004, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol_Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
February 3, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
June 14, 2012
Record last verified: 2012-06