Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Drug: BMS-779788; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836602

CV197-002

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women (not of child bearing potential) ages 18 to 45
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion criteria

• Women of child bearing potential
• 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: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 3 patient groups

BMS-779788 or Placebo (Arm 1)

Active Comparator group

Treatment:

Drug: BMS-779788

Drug: BMS-779788

Drug: BMS-779788

Drug: Placebo

BMS-779788 or Placebo (Arm 2)

Active Comparator group

Treatment:

Drug: BMS-779788

Drug: BMS-779788

Drug: BMS-779788

Drug: Placebo

BMS-779788 or Placebo (Arm 3)

Active Comparator group

Treatment:

Drug: BMS-779788

Drug: BMS-779788

Drug: BMS-779788

Drug: Placebo