Overview

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

Status:
Completed

Trial end date:
2015-02-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

BMS-986120
Midazolam

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
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