Safety Study to Evaluate BMS-830216 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: BMS-830216; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878020

MB123-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
• Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45

Exclusion criteria

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Arm 1

Active Comparator group

Description:

BMS-830216 (10 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216

Arm 2

Active Comparator group

Description:

BMS-830216 (30 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216

Arm 3

Active Comparator group

Description:

BMS-830216 (100 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216

Arm 4

Active Comparator group

Description:

BMS-830216 (300 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216

Arm 5

Active Comparator group

Description:

BMS-830216 (600 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216

Arm 6

Active Comparator group

Description:

BMS-830216 (1200 mg)

Treatment:

Drug: Placebo

Drug: BMS-830216

Drug: Placebo

Drug: BMS-830216