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

Primary Purpose

Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-BMS-986327

About this trial

This is an interventional diagnostic trial for Healthy Participants focused on measuring Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Local Institution - 0001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1

Part 2

Part 3

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)

Incidence of serious adverse events (SAEs)

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

Test-retest repeatability

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04069143

First Posted

August 22, 2019

Last Updated

March 6, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04069143

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

July 12, 2022 (Actual)

Study Completion Date

July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1

Arm Type

Experimental

Arm Title

Part 2

Arm Type

Experimental

Arm Title

Part 3

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

18F-BMS-986327

Intervention Description

Imaging Agent

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Time Frame

Up to 3 days after participant's participation

Title

Incidence of serious adverse events (SAEs)

Time Frame

Up to 30 days after participant's participation

Title

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

Time Frame

30 days after participant's participation

Title

Test-retest repeatability

Time Frame

30 days after participant's participation

Title

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

Time Frame

30 days after participant's participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0001

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520-8048

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

Investigator Inquiry Form

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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