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

Healthy Volunteers Clinical Trial

— NHV  

Official title:

Effects of Metformin on Glucose Homeostasis Following Administration of BMS-754807 in Healthy Volunteer Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525823
• Other study ID #: CA191-015
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2012
• Last updated: June 13, 2012
• Start date: February 2012
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-754807 (IGR-IR/IR Inhibitor)
Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
• Metformin
Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Safety endpoints: AEs and marked clinical laboratory abnormalities	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	Day -21 to Day 47	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration [AUC(0-T)] 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	No
Secondary	Plasma half-life (T-HALF) of BMS-754807 and M5		12 timepoints over 72 hours for the Day 5 dose	No
Secondary	Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) 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	No
Secondary	Mean levels of plasma glucose, serum insulin and c-peptide		Day 3, Day 5 and Day 17	No