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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adult Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel 1: BMS-986120 or Placebo

BMS-986120 or Placebo multiple dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986120

Intervention Type DRUG

Placebo

Intervention Type DRUG

Panel 2: BMS-986120 or Placebo

BMS-986120 or Placebo multiple dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986120

Intervention Type DRUG

Placebo

Intervention Type DRUG

Panel 3: BMS-986120 or Placebo + Midazolam

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

Group Type EXPERIMENTAL

BMS-986120

Intervention Type DRUG

Placebo

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Panel 4: BMS-986120 or Placebo

BMS-986120 or Placebo multiple dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986120

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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BMS-986120

Intervention Type DRUG

Placebo

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes