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
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, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014