Safety and Pharmacology Study of BMS-866949

Phase 1TerminatedNCT01124344

Bristol-Myers Squibb47 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depression

Interventions

PlaceboDRUG

Oral Solution, Oral, 0 mg, Once Daily, 14 days

BMS-866949DRUG

Oral Solution, Oral, 3 mg, Once Daily, 14 days

BMS-866949DRUG

Oral Solution, Oral, 10 mg, Once Daily, 14 days

BMS-866949

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Uppsala, Sweden

Outcomes

Primary Outcomes

Assessment of safety by evaluating incidence of adverse events (AE)

Time frame: Over a period of 28 days (+/- 2 days) of first dose

Secondary Outcomes

Assessment of pharmacokinetics by evaluating plasma concentration versus time data

Time frame: Over a period 28 days (+/- 2 days) of first dose

Assessment of pharmacodynamics by evaluating brain transporter occupancy

Time frame: Over a period 28 days (+/- 2 days) of first dose

Data from ClinicalTrials.gov

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