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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: Placebo; Drug: BMS-903452

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240980

MB125-001

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 12 patient groups

BMS-903452 (0.1 mg) or Placebo - A1

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (0.6 mg) or Placebo - A2

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (3.0 mg) or Placebo - A3

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (10 mg) or Placebo - A4

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (30 mg) or Placebo - A5

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (60 mg) or Placebo - A6

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (120 mg) or Placebo - A7

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (0.6 mg) or Placebo - B1

Experimental group

Description:

(Subjects with type 2 Diabetes Mellitus)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (10 mg) or Placebo - B2

Experimental group

Description:

(Subjects with type 2 Diabetes Mellitus)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (120 mg) or Placebo - B3

Experimental group

Description:

(Subjects with type 2 Diabetes Mellitus)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (10 mg) or Placebo - A11

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

BMS-903452 (60 mg) or Placebo - A12

Experimental group

Description:

(Healthy Subjects)

Treatment:

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo

Drug: BMS-903452

Drug: BMS-903452

Drug: BMS-903452

Drug: Placebo