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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04069143
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Part 1

Experimental: Part 2

Experimental: Part 3

Interventions

Diagnostic Test: - 18F-BMS-986327

Imaging Agent

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale Positron Emission Tomography Center, New Haven, Connecticut

Status

Recruiting

Address

Yale Positron Emission Tomography Center

New Haven, Connecticut, 06520-8048

Site Contact

Richard Carson, Site 0001

Clinical.Trials@bms.com

855-907-3286

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