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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis (IPF); Healthy Participants

Treatments: Diagnostic Test: 18F-BMS-986327

Study type: Interventional

Funder types: Industry

Identifiers

NCT04069143

IM033-002

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Part 1

Experimental group

Treatment:

Diagnostic Test: 18F-BMS-986327

Part 2

Experimental group

Treatment:

Diagnostic Test: 18F-BMS-986327

Part 3

Experimental group

Treatment:

Diagnostic Test: 18F-BMS-986327