Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Adult Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[Height(m)\]2
- Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive
Exclusion
- 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
- 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
- Hemoglobin or hematocrit or platelet count \<lower limit of normal (LLN)
- Bleeding time exceeding 8 minutes at pre-dose on Day -1
- 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
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 12 weeks of study drug administration
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02208882
Start Date
August 1 2014
End Date
February 1 2015
Last Update
July 7 2015
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744