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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01240980
First received: November 11, 2010
Last updated: March 14, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: BMS-903452
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism [ Time Frame: Within 2 days of study drug administration ] [ Designated as safety issue: No ]
  • Effect on electrocardiographic (ECG) parameters [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: Yes ]
  • Percent urinary recovery (% UR) [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: No ]
    derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses

  • Renal clearance (CLR) from plasma [ Time Frame: Within 10 days of study drug administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Within 10 days after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-903452 (0.1 mg) or Placebo - A1
(Healthy Subjects)
Drug: BMS-903452
Solution, Oral, 0.1 mg, once daily, 1 day
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (0.6 mg) or Placebo - A2
(Healthy Subjects)
Drug: BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (3.0 mg) or Placebo - A3
(Healthy Subjects)
Drug: BMS-903452
Suspension, Oral, 3.0 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (10 mg) or Placebo - A4
(Healthy Subjects)
Drug: BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (30 mg) or Placebo - A5
(Healthy Subjects)
Drug: BMS-903452
Suspension, Oral, 30 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (60 mg) or Placebo - A6
(Healthy Subjects)
Drug: BMS-903452
Suspension, Oral, 60 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (120 mg) or Placebo - A7
(Healthy Subjects)
Drug: BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (0.6 mg) or Placebo - B1
(Subjects with type 2 Diabetes Mellitus)
Drug: Placebo
Solution, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Solution, Oral, 0.6 mg, once daily, 1 day
Experimental: BMS-903452 (10 mg) or Placebo - B2
(Subjects with type 2 Diabetes Mellitus)
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Suspension, Oral, 10 mg, once daily, 1 day
Experimental: BMS-903452 (120 mg) or Placebo - B3
(Subjects with type 2 Diabetes Mellitus)
Drug: Placebo
Suspension, Oral, 0 mg, once daily, 1 day
Drug: BMS-903452
Suspension, Oral, 120 mg, once daily, 1 day
Experimental: BMS-903452 (10 mg) or Placebo - A11
(Healthy Subjects)
Drug: BMS-903452
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
Drug: Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
Experimental: BMS-903452 (60 mg) or Placebo - A12
(Healthy Subjects)
Drug: BMS-903452
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Drug: Placebo
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240980

Locations
United States, Florida
Comprehensive Phase One
Miramar, Florida, United States, 33025
United States, Texas
Ppd Development, Lp
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01240980     History of Changes
Other Study ID Numbers: MB125-001
Study First Received: November 11, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014