Safety and Pharmacology Study of BMS-866949

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Major Depression

Treatments: Drug: BMS-866949; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01124344

2010-018461-38 (EudraCT Number)

CN166-002

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 7 patient groups

Placebo or BMS-866949 (3 mg)

Active Comparator group

Description:

Panel 1: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (10 mg)

Active Comparator group

Description:

Panel 2: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (30 mg)

Active Comparator group

Description:

Panel 3: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (45 mg)

Active Comparator group

Description:

Panel 4: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (60 mg)

Active Comparator group

Description:

Panel 5: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (90 mg)

Active Comparator group

Description:

Panel 6: Healthy Male Subjects

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo

Placebo or BMS-866949 (3 - 60 mg)

Active Comparator group

Description:

Panel 7: Females

Treatment:

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: BMS-866949

Drug: Placebo