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Completed

NCT Number: NCT00949767

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Uppsala, 751 23, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

BMS-866949

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs

    Time frame: up to Day 14 +/- 2 days post-dose

Secondary outcomes

  1. Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples

    Time frame: Blood samples will be taken up to 144 hour post-dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2009
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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