Single Ascending Dose (BMS-813160) Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Accelerated Intimal Hyperplasia

Treatments: Drug: [14C] BMS-813160; Drug: Placebo; Drug: BMS-813160

Study type: Interventional

Funder types: Industry

Identifiers

NCT01049165

CV202-001

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects

Enrollment: 70 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
• Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 9 patient groups

Arm 1 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 2 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 3 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 4 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 5 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 6 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 7 [14C] BMS-813160

Active Comparator group

Treatment:

Drug: [14C] BMS-813160

Arm 8 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: Placebo

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Arm 9 (BMS-813160 or placebo)

Active Comparator group

Treatment:

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160

Drug: BMS-813160