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BMS-816336

Phase 1

Diabetes Mellitus, Non-Insulin-Dependent | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Feb 23, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BMS-816336 · 1 trial · 2 indications

Phase 1 1
NCT00979368Safety Study of BMS-816336 in Healthy Male SubjectsDiabetes Mellitus, Non-Insulin-Dependent
COMPLETED40 Analytics
PHASE1COMPLETED
Safety Study of BMS-816336 in Healthy Male Subjects
Diabetes Mellitus, Non-Insulin-DependentUnlock trial analytics

Study Endpoints

Primary Endpoints

Exposure to the investigational drug will be measured to assess safety and tolerability
Within 72 hours following dosing

Secondary Endpoints

To assess the single dose Pharmacokinetics of BMS-816336
During 72 hours following dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
BMS-816336 or placebo (Panel 1)ACTIVE_COMPARATOR -
BMS-816336 or placebo (Panel 2)ACTIVE_COMPARATOR -
BMS-816336 or placebo (Panel 3)ACTIVE_COMPARATOR -
BMS-816336 or placebo (Panel 4)ACTIVE_COMPARATOR -
BMS-816336 or placebo (Panel 5)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BMS-816336DRUGSuspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
PlaceboDRUGSuspension, Oral, 0 mg, Once on Day 1 only, 4 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects * BMI of 18 to 32 kg/m² * Men only, ages 18-55 years Exclusion Criteria: * Sexually active men not using effective birth control if their partners are WOCBP * Any significant acute or chronic medical illness * Family history of Gilbert's disease * Histo...

Countries:Australia
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Frequently asked questions about BMS-816336

What is BMS-816336 used for?

BMS-816336 is an investigational small molecule being studied for the treatment of non-insulin-dependent diabetes mellitus, also known as type 2 diabetes. It is being developed by Bristol-Myers Squibb Company. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes BMS-816336?

BMS-816336 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of non-insulin-dependent diabetes mellitus.

What phase is BMS-816336 in?

BMS-816336 is currently in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which studied the safety of BMS-816336 in healthy male subjects.

What clinical trials is BMS-816336 in?

BMS-816336 has one completed clinical trial registered under NCT00979368, titled "Safety Study of BMS-816336 in Healthy Male Subjects." This Phase 1 trial enrolled 40 participants in Australia and was a randomized, double-blind, active-controlled study.

How does BMS-816336 work?

The molecular target of BMS-816336 has not been disclosed in available information. As a small molecule, it is designed to interact with biological pathways involved in glucose metabolism, but the specific mechanism of action has not been publicly detailed.