Clinical trial NCT04069143: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Idiopathic Pulmonary Fibrosis (IPF)
Keywords: Healthy Participants
Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 3 days after participant's participation
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 30 days after participant's participation
measure: Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
timeFrame: 30 days after participant's participation
measure: Test-retest repeatability
timeFrame: 30 days after participant's participation
measure: Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
timeFrame: 30 days after participant's participation
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Local Institution - 0001
state: Connecticut
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: