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BMS-866949

Phase 1

Depression | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

BMS-866949 · 1 trial · 1 indication

Phase 1 1
NCT00949767Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy SubjectsDepression
COMPLETED64 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
up to Day 14 +/- 2 days post-dose

Secondary Endpoints

Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
Blood samples will be taken up to 144 hour post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
BMS-866949 (Panel 1)EXPERIMENTAL -
BMS-866949 (Panel 2)EXPERIMENTAL -
BMS-866949 (Panel 3)EXPERIMENTAL -
BMS-866949 (Panel 4)EXPERIMENTAL -
BMS-866949 (Panel 5)EXPERIMENTAL -
BMS-866949 (Panel 6)EXPERIMENTAL -
BMS-866949 (Panel 7)EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-866949DRUG(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
PlaceboDRUG(Matching volume) - Oral Solution, Oral, once 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male 18-55 * Women not of child bearing potential, 18-55 Exclusion Criteria: * History of or current treatment for psychiatric illnesses, substance abuse or dependence * History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, ...

Countries:Sweden
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Frequently asked questions about BMS-866949

What is BMS-866949 used for?

BMS-866949 is an investigational small molecule being developed for the treatment of depression. It is in Phase 1 clinical development, meaning it is still being studied and has not been approved for any use. The drug is being evaluated for its safety, pharmacokinetics, and pharmacodynamics in clinical trials.

Who makes BMS-866949?

BMS-866949 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and pharmacological properties in healthy subjects.

What phase is BMS-866949 in?

BMS-866949 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical research for the treatment of depression.

What clinical trials is BMS-866949 in?

BMS-866949 has one completed clinical trial, identified as NCT00949767. This Phase 1 study, titled "Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects," was conducted in Sweden with 64 participants. The trial was randomized, double-blind, and controlled, enrolling healthy volunteers aged 18 years and older.

Is BMS-866949 FDA approved?

BMS-866949 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for depression. The completed Phase 1 trial focused on safety and pharmacological parameters in healthy subjects, and the drug has not yet progressed to later-stage trials or regulatory approval.