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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Volunteers

In brief

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.

Key facts

Study ID

NCT02208882

Run by

Bristol-Myers Squibb

People needed

24

Starts

2014-08-01

Expected to finish

2015-02-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

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