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
Overview
- Phase
- Phase 1
- Intervention
- BMS-903452
- Conditions
- Diabetes
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
Intervention: Placebo
BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
Intervention: BMS-903452
BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
Intervention: Placebo
BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
Intervention: BMS-903452
BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
Intervention: Placebo
BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
Intervention: BMS-903452
BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
Intervention: Placebo
BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
Intervention: BMS-903452
BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Time Frame: Within 10 days of study drug administration
Secondary Outcomes
- 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)
- Renal clearance (CLR) from plasma(Within 10 days of study drug administration)
- 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)