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)

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: BMS-903452; Drug: Placebo

• Registration Number: NCT01240980
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Status Verified: 2011-11
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

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Exclusion Criteria

• Type 1 Diabetes
• History of significant heart disease
• Prior bariatric surgery
• Women of childbearing potential

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-903452 (0.1 mg) or Placebo - A1	BMS-903452	(Healthy Subjects)
BMS-903452 (0.1 mg) or Placebo - A1	Placebo	(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - A2	BMS-903452	(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - A2	Placebo	(Healthy Subjects)
BMS-903452 (3.0 mg) or Placebo - A3	BMS-903452	(Healthy Subjects)
BMS-903452 (3.0 mg) or Placebo - A3	Placebo	(Healthy Subjects)
BMS-903452 (10 mg) or Placebo - A4	Placebo	(Healthy Subjects)
BMS-903452 (30 mg) or Placebo - A5	Placebo	(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A6	Placebo	(Healthy Subjects)
BMS-903452 (120 mg) or Placebo - A7	Placebo	(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - B1	Placebo	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - B2	Placebo	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (120 mg) or Placebo - B3	Placebo	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - A11	Placebo	(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A12	Placebo	(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A12	BMS-903452	(Healthy Subjects)
BMS-903452 (120 mg) or Placebo - B3	BMS-903452	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (0.6 mg) or Placebo - B1	BMS-903452	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - B2	BMS-903452	(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - A11	BMS-903452	(Healthy Subjects)
BMS-903452 (10 mg) or Placebo - A4	BMS-903452	(Healthy Subjects)
BMS-903452 (30 mg) or Placebo - A5	BMS-903452	(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A6	BMS-903452	(Healthy Subjects)
BMS-903452 (120 mg) or Placebo - A7	BMS-903452	(Healthy Subjects)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism	Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters	Within 10 days of study drug administration
Percent urinary recovery (% UR)	Within 10 days of study drug administration	derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Renal clearance (CLR) from plasma	Within 10 days of study drug administration	derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
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
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
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
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
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
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

Trial Locations

Locations (2)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States

Comprehensive Phase One; 🇺🇸 Miramar, Florida, United States