A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327
NCT ID: NCT04069143
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2019-10-01
2022-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Part 1
18F-BMS-986327
Imaging Agent
Part 2
18F-BMS-986327
Imaging Agent
Part 3
18F-BMS-986327
Imaging Agent
Interventions
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18F-BMS-986327
Imaging Agent
Eligibility Criteria
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Inclusion Criteria
· 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
* 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
18 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
New Haven, Connecticut, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM033-002
Identifier Type: -
Identifier Source: org_study_id
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