Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: BMS-986120; Drug: Placebo; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02208882

CV004-006

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.

Enrollment: 24 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, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants

2. Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:

   • i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
   • ii) Total bilirubin >ULN, thyroid-stimulating hormone (TSH) >1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)
   • iii) CK >3 x ULN (unless exercise related and CK-MB within normal limits)
   • iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) >ULN
   • v) Blood urea nitrogen (BUN) or creatinine (Cr) >ULN

3. Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)

4. Bleeding time exceeding 8 minutes at pre-dose on Day -1

5. Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor

6. Any significant acute or chronic medical illness

7. Current or recent (within 3 months of study drug administration) gastrointestinal disease

8. Any major surgery within 12 weeks of study drug administration

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Panel 1: BMS-986120 or Placebo

Experimental group

Description:

BMS-986120 or Placebo multiple dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986120

Panel 2: BMS-986120 or Placebo

Experimental group

Description:

BMS-986120 or Placebo multiple dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986120

Panel 3: BMS-986120 or Placebo + Midazolam

Experimental group

Description:

BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified

Treatment:

Drug: Midazolam

Drug: Placebo

Drug: BMS-986120

Panel 4: BMS-986120 or Placebo

Experimental group

Description:

BMS-986120 or Placebo multiple dose by mouth as specified

Treatment:

Drug: Placebo

Drug: BMS-986120