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Recruiting

A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327 - IM033-002

Updated: 30 March, 2022   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1
Diagnostic Test: 18F-BMS-986327
Experimental: Part 2
Diagnostic Test: 18F-BMS-986327
Experimental: Part 3
Diagnostic Test: 18F-BMS-986327

Key Eligibility Criteria

Inclusion Criteria: All Participants: · Body mass index of 18.0 to 34.0 kg/m^2, inclusive, and body weight ≥ 50 kg Healthy Participants: - Male and female healthy volunteers ages 18 or age or older - No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory determinations Idiopathic Pulmonary Fibrosis (IPF) Participants: - Male and female participants aged 40 to 90 years - Diagnosis of IPF less than 6 years before randomization - Have no features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage or surgical lung biopsy Exclusion Criteria (all participants): - Severe motor problems that prevent the ability to lie still for PET imaging procedure - Significant acute or chronic medical illness in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of 18F-BMS-986327 - Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug - Any major surgery within 4 weeks of study drug administration Other protocol-defined criteria apply

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

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com