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BMS-903452

Phase 1

Diabetes | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Mar 15, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

BMS-903452 · 1 trial · 1 indication

Phase 1 1
NCT01240980Safety 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)Diabetes
COMPLETED104 Analytics
PHASE1COMPLETED
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)
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Within 10 days of study drug administration

Secondary Endpoints

Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters
Within 10 days of study drug administration
Percent urinary recovery (% UR)
Within 10 days of study drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-903452 (0.1 mg) or Placebo - A1EXPERIMENTAL(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - A2EXPERIMENTAL(Healthy Subjects)
BMS-903452 (3.0 mg) or Placebo - A3EXPERIMENTAL(Healthy Subjects)
BMS-903452 (10 mg) or Placebo - A4EXPERIMENTAL(Healthy Subjects)
BMS-903452 (30 mg) or Placebo - A5EXPERIMENTAL(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A6EXPERIMENTAL(Healthy Subjects)
BMS-903452 (120 mg) or Placebo - A7EXPERIMENTAL(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - B1EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - B2EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (120 mg) or Placebo - B3EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - A11EXPERIMENTAL(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A12EXPERIMENTAL(Healthy Subjects)

Interventions

NameTypeDescription
BMS-903452DRUGSolution, Oral, 0.1 mg, once daily, 1 day
PlaceboDRUGSolution, Oral, 0 mg, once daily, 1 day
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

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

Countries:United States
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about BMS-903452

What is BMS-903452 used for?

BMS-903452 is an investigational small molecule being developed for the treatment of diabetes. It is a metabolic therapy that has been studied in healthy subjects and in patients with type 2 diabetes mellitus. The drug is currently in Phase 1 clinical development and is not yet approved.

Who makes BMS-903452?

BMS-903452 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and bioavailability of this investigational drug for diabetes.

What phase is BMS-903452 in?

BMS-903452 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and relative bioavailability in healthy subjects and in patients with type 2 diabetes mellitus.

What clinical trials is BMS-903452 in?

BMS-903452 has one completed Phase 1 clinical trial registered under NCT01240980. This study evaluated the safety of the drug in healthy subjects and assessed the relative bioavailability of its crystalline and amorphous forms, as well as its effects in subjects with type 2 diabetes mellitus. The trial enrolled 104 participants in the United States.

Is BMS-903452 the same as any other drug?

No alternative names for BMS-903452 have been disclosed. The drug is identified solely by its development code, BMS-903452, and is being investigated by Bristol-Myers Squibb for the treatment of diabetes.