Safety Study to Evaluate BMS-830216 in Healthy Subjects

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Drug: Placebo
Drug: BMS-830216

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

48 participants in 6 patient groups

Arm 1
Active Comparator group
Description:
BMS-830216 (10 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo
Arm 2
Active Comparator group
Description:
BMS-830216 (30 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo
Arm 3
Active Comparator group
Description:
BMS-830216 (100 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo
Arm 4
Active Comparator group
Description:
BMS-830216 (300 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo
Arm 5
Active Comparator group
Description:
BMS-830216 (600 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo
Arm 6
Active Comparator group
Description:
BMS-830216 (1200 mg)
Treatment:
Drug: BMS-830216
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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