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

NCT04069143 | Completed Phase 1 FDA Drug

• 1 other identifier: IM033-002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Participants; Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Healthy Participants; Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Study Arms (3)

Part 1

EXPERIMENTAL

Diagnostic Test: 18F-BMS-986327

Part 2

EXPERIMENTAL

Diagnostic Test: 18F-BMS-986327

Part 3

EXPERIMENTAL

Diagnostic Test: 18F-BMS-986327

Interventions

18F-BMS-986327 DIAGNOSTIC_TEST

Imaging Agent

Part 1; Part 2; Part 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

New Haven, Connecticut, 06520-8048, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2019
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

US (1)