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

Healthy Participants Clinical Trial

Official title:

An Open-Label Study to Evaluate the Safety, Tolerability, Kinetics, and Repeatability of the Novel Lysophosphatidic Acid Receptor 1 (LPA1) Positron Emission Tomography (PET) Ligand 18F-BMS-986327

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069143
• Other study ID #: IM033-002
• Status: Completed
• Phase: Phase 1
• 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
• 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:

· 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

Related Conditions & MeSH terms

• Fibrosis
• Healthy Participants
• Idiopathic Pulmonary Fibrosis
• Idiopathic Pulmonary Fibrosis (IPF)
• Pulmonary Fibrosis

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form