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

Phase 1

Completed

• Conditions: Healthy Participants; Idiopathic Pulmonary Fibrosis (IPF)
• Interventions: Diagnostic Test: 18F-BMS-986327

• Registration Number: NCT04069143
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-10-01
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 3	18F-BMS-986327	-
Part 1	18F-BMS-986327	-
Part 2	18F-BMS-986327	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 New Haven, Connecticut, United States