Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: BMS-986141; Drug: Placebo; Drug: Aspirin; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02341638

CV006-003

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

Full description

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Enrollment: 148 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[height(m)]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria:

1. Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
2. Other protocol-defined exclusion criteria could apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 17 patient groups, including a placebo group

Part A Panel 1: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 2: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 3: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 4: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 5: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 6: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo single dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part A Panel 7: BMS-986141

Experimental group

Description:

Single dose by mouth as specified

Treatment:

Drug: BMS-986141

Part A Panel 8: BMS-986141

Experimental group

Description:

Single dose by mouth as specified

Treatment:

Drug: BMS-986141

Part B Panel 1: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part B Panel 2: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part B Panel 3: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part C Panel 1: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part C Panel 2: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part C Panel 3: BMS-986141 or Placebo

Experimental group

Description:

BMS-986141 or Placebo by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986141

Part D Panel 1: BMS-986141 and Aspirin

Experimental group

Description:

BMS-986141 and Aspirin by mouth as specified

Treatment:

Drug: Aspirin

Drug: BMS-986141

Part D Panel 1: Placebo matching BMS-986141 and Aspirin

Placebo Comparator group

Description:

BMS-986141 placebo and Aspirin by mouth as specified

Treatment:

Drug: Aspirin

Drug: Placebo

Part E Panel 1: BMS-986141 and Itraconazole

Experimental group

Description:

BMS-986141 and Itraconazole by mouth as specified

Treatment:

Drug: BMS-986141

Drug: Itraconazole