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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04069143
Other study ID # IM033-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2019
Est. completion date July 12, 2022

Study information

Verified date March 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 participants and participants with idiopathic pulmonary fibrosis (IPF).


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 12, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All Participants: ยท 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
18F-BMS-986327
Imaging Agent

Locations

Country Name City State
United States Local Institution - 0001 New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) Up to 3 days after participant's participation
Primary Incidence of serious adverse events (SAEs) Up to 30 days after participant's participation
Primary Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images 30 days after participant's participation
Primary Test-retest repeatability 30 days after participant's participation
Primary Biodistribution and lung uptake calculated from PET-CT images in participants with IPF 30 days after participant's participation
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