Safety and Pharmacology Study of BMS-866949

Phase 1

Terminated

• Conditions: Major Depression
• Interventions: Drug: Placebo; Drug: BMS-866949

• Registration Number: NCT01124344
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Panels 1-6: Healthy Male Subjects
• Panel 7: Females
• Ages 21 to 55, inclusive
• Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

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Exclusion Criteria

• History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
• History or family history of psychiatric disorder
• Current treatment with prescription medication
• Exposure to any investigational drug or placebo within 12 weeks of study drug administration

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo or BMS-866949 (3 mg)	Placebo	Panel 1: Healthy Male Subjects
Placebo or BMS-866949 (3 mg)	BMS-866949	Panel 1: Healthy Male Subjects
Placebo or BMS-866949 (10 mg)	Placebo	Panel 2: Healthy Male Subjects
Placebo or BMS-866949 (10 mg)	BMS-866949	Panel 2: Healthy Male Subjects
Placebo or BMS-866949 (30 mg)	Placebo	Panel 3: Healthy Male Subjects
Placebo or BMS-866949 (30 mg)	BMS-866949	Panel 3: Healthy Male Subjects
Placebo or BMS-866949 (45 mg)	Placebo	Panel 4: Healthy Male Subjects
Placebo or BMS-866949 (45 mg)	BMS-866949	Panel 4: Healthy Male Subjects
Placebo or BMS-866949 (60 mg)	Placebo	Panel 5: Healthy Male Subjects
Placebo or BMS-866949 (60 mg)	BMS-866949	Panel 5: Healthy Male Subjects
Placebo or BMS-866949 (90 mg)	Placebo	Panel 6: Healthy Male Subjects
Placebo or BMS-866949 (90 mg)	BMS-866949	Panel 6: Healthy Male Subjects
Placebo or BMS-866949 (3 - 60 mg)	Placebo	Panel 7: Females
Placebo or BMS-866949 (3 - 60 mg)	BMS-866949	Panel 7: Females

Primary Outcome Measures

Name	Time	Method
Assessment of safety by evaluating incidence of adverse events (AE)	Over a period of 28 days (+/- 2 days) of first dose

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetics by evaluating plasma concentration versus time data	Over a period 28 days (+/- 2 days) of first dose
Assessment of pharmacodynamics by evaluating brain transporter occupancy	Over a period 28 days (+/- 2 days) of first dose

Trial Locations

Locations (1)

Local Institution; 🇸🇪 Uppsala, Sweden