Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)

Diabetes Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-903452 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240980
• Other study ID #: MB125-001
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2010
• Last updated: March 14, 2012
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: November 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy

Exclusion Criteria:

• Type 1 Diabetes

• History of significant heart disease

• Prior bariatric surgery

• Women of childbearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
• BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
• Placebo
Solution, Oral, 0 mg, once daily, 1 day
• Placebo
Suspension, Oral, 0 mg, once daily, 1 day
• BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
• BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
• Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
• BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
• BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas
United States	Comprehensive Phase One	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments		Within 10 days of study drug administration	Yes
Secondary	Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism		Within 2 days of study drug administration	No
Secondary	Effect on electrocardiographic (ECG) parameters		Within 10 days of study drug administration	Yes
Secondary	Percent urinary recovery (% UR)	derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses	Within 10 days of study drug administration	No
Secondary	Renal clearance (CLR) from plasma	derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses	Within 10 days of study drug administration	No
Secondary	The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No
Secondary	The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No
Secondary	The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No
Secondary	The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No
Secondary	The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No
Secondary	The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data		Within 10 days after study drug administration	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form