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

March 6, 2023 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8048
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Diagnostic test: 18F-BMS-986327
Imaging Agent
Experimental: Part 2
Diagnostic test: 18F-BMS-986327
Imaging Agent
Experimental: Part 3
Diagnostic test: 18F-BMS-986327
Imaging Agent

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

July 12, 2022

Study Completion (Actual)

July 12, 2022

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM033-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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