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Active, Not Recruiting

A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants - IM031-002

Updated: 20 November, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18-55

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: Monotherapy MAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318
Experimental: Monotherapy SAD BMS-986318 or Placebo
Other: Placebo Drug: BMS-986318

Key Eligibility Criteria

Inclusion Criteria: - Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator - Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days. - Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment. Exclusion Criteria: - Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration - Women of Child Bearing Potential (WOCBP) or women who are breastfeeding. - Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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