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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Not applicable
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01525823