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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01525823




Registration number
NCT01525823
Ethics application status
Date submitted
18/01/2012
Date registered
3/02/2012
Date last updated
14/06/2012

Titles & IDs
Public title
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
Scientific title
Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects
Secondary ID [1] 0 0
CA191-015
Universal Trial Number (UTN)
Trial acronym
NHV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-754807 (IGR-IR/IR Inhibitor)
Treatment: Drugs - Metformin

Experimental: BMS-754807 + Metformin -


Treatment: Drugs: BMS-754807 (IGR-IR/IR Inhibitor)
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17

Treatment: Drugs: Metformin
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
Timepoint [1] 0 0
On Day 3 and Day 17
Secondary outcome [1] 0 0
Safety endpoints: AEs and marked clinical laboratory abnormalities
Timepoint [1] 0 0
Day -21 to Day 47
Secondary outcome [2] 0 0
Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
Timepoint [2] 0 0
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [3] 0 0
Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
Timepoint [3] 0 0
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-754807 and M5
Timepoint [4] 0 0
12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-754807 and M5
Timepoint [5] 0 0
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [6] 0 0
Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] of BMS-754807 and M5
Timepoint [6] 0 0
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [7] 0 0
Plasma half-life (T-HALF) of BMS-754807 and M5
Timepoint [7] 0 0
12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [8] 0 0
Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-754807 and M5
Timepoint [8] 0 0
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Secondary outcome [9] 0 0
Mean levels of plasma glucose, serum insulin and c-peptide
Timepoint [9] 0 0
Day 3, Day 5 and Day 17

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01525823
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol_Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries