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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:
ClinicalTrials.gov Identifier:
NCT01240980
First Posted: November 15, 2010
Last Update Posted: March 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

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 ]

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 ]
  • Effect on electrocardiographic (ECG) parameters [ Time Frame: Within 10 days of study drug administration ]
  • Percent urinary recovery (% UR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within 10 days after study drug administration ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01240980     History of Changes
Other Study ID Numbers: MB125-001
First Submitted: November 11, 2010
First Posted: November 15, 2010
Last Update Posted: March 15, 2012
Last Verified: November 2011

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