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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)

Primary Purpose

Diabetes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-903452
BMS-903452
BMS-903452
BMS-903452
BMS-903452
BMS-903452
BMS-903452
Placebo
Placebo
BMS-903452
BMS-903452
Placebo
BMS-903452
BMS-903452
BMS-903452
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Comprehensive Phase One
  • Ppd Development, Lp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

BMS-903452 (0.1 mg) or Placebo - A1

BMS-903452 (0.6 mg) or Placebo - A2

BMS-903452 (3.0 mg) or Placebo - A3

BMS-903452 (10 mg) or Placebo - A4

BMS-903452 (30 mg) or Placebo - A5

BMS-903452 (60 mg) or Placebo - A6

BMS-903452 (120 mg) or Placebo - A7

BMS-903452 (0.6 mg) or Placebo - B1

BMS-903452 (10 mg) or Placebo - B2

BMS-903452 (120 mg) or Placebo - B3

BMS-903452 (10 mg) or Placebo - A11

BMS-903452 (60 mg) or Placebo - A12

Arm Description

(Healthy Subjects)

(Healthy Subjects)

(Healthy Subjects)

(Healthy Subjects)

(Healthy Subjects)

(Healthy Subjects)

(Healthy Subjects)

(Subjects with type 2 Diabetes Mellitus)

(Subjects with type 2 Diabetes Mellitus)

(Subjects with type 2 Diabetes Mellitus)

(Healthy Subjects)

(Healthy Subjects)

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2010
Last Updated
March 14, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01240980
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-903452 (0.1 mg) or Placebo - A1
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (0.6 mg) or Placebo - A2
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (3.0 mg) or Placebo - A3
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (10 mg) or Placebo - A4
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (30 mg) or Placebo - A5
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (60 mg) or Placebo - A6
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (120 mg) or Placebo - A7
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (0.6 mg) or Placebo - B1
Arm Type
Experimental
Arm Description
(Subjects with type 2 Diabetes Mellitus)
Arm Title
BMS-903452 (10 mg) or Placebo - B2
Arm Type
Experimental
Arm Description
(Subjects with type 2 Diabetes Mellitus)
Arm Title
BMS-903452 (120 mg) or Placebo - B3
Arm Type
Experimental
Arm Description
(Subjects with type 2 Diabetes Mellitus)
Arm Title
BMS-903452 (10 mg) or Placebo - A11
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Arm Title
BMS-903452 (60 mg) or Placebo - A12
Arm Type
Experimental
Arm Description
(Healthy Subjects)
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Solution, Oral, 0.1 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Solution, Oral, 0.6 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 3.0 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 10 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 30 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 60 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 120 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution, Oral, 0 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Suspension, Oral, 0 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Solution, Oral, 0.6 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 10 mg, once daily, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-903452
Intervention Description
Suspension, Oral, 120 mg, once daily, 1 day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Time Frame
Within 2 days of study drug administration
Title
Effect on electrocardiographic (ECG) parameters
Time Frame
Within 10 days of study drug administration
Title
Percent urinary recovery (% UR)
Description
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Time Frame
Within 10 days of study drug administration
Title
Renal clearance (CLR) from plasma
Description
derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses
Time Frame
Within 10 days of study drug administration
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Phase One
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Ppd Development, Lp
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

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