Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Idiopathic Pulmonary Fibrosis (IPF)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability, kinetics and test-retest repeatability of the novel LPA1 positron emission tomography (PET) ligand 18F-BMS-986327 in healthy participan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04069143
Start Date
October 1 2019
End Date
July 12 2022
Last Update
March 7 2023
Active Locations (1)
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1
Local Institution - 0001
New Haven, Connecticut, United States, 06520-8048