Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949767

Enrollment

Registered

2009-07-30

Start date

2009-07-31

Completion date

2010-03-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief summary

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.

Interventions

DRUGBMS-866949

(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days

DRUGPlacebo

(Matching volume) - Oral Solution, Oral, once 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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, etc.)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026