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Completed

NCT Number: NCT04069143

A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 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).

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Key information

Conditions

Healthy Participants Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

New Haven, Connecticut, 06520-8048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-BMS-986327

Diagnostic Test

Imaging Agent

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 3 days after participant's participation

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 30 days after participant's participation

  3. Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images

    Time frame: 30 days after participant's participation

  4. Test-retest repeatability

    Time frame: 30 days after participant's participation

  5. Biodistribution and lung uptake calculated from PET-CT images in participants with IPF

    Time frame: 30 days after participant's participation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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