Healthy ParticipantsPhase 1NCT04069143
A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327
A Phase 1 study testing 18F-BMS-986327 in people with Healthy Participants and Idiopathic Pulmonary Fibrosis (IPF), run by Bristol-Myers Squibb at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- 18F-BMS-986327
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 12 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
New Haven, Connecticut, 06520-8048
About this study
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
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).
- Being tested
- 18F-BMS-986327
- Keywords
- Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-BMS-986327Diagnostic test
Imaging Agent
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Diagnostic Test: 18F-BMS-986327 |
| Part 2 | Experimental | Not described Receives: Diagnostic Test: 18F-BMS-986327 |
| Part 3 | Experimental | Not described Receives: Diagnostic Test: 18F-BMS-986327 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 3 days after participant's participation
Incidence of serious adverse events (SAEs)
Measured: Up to 30 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
Measured: 30 days after participant's participation
Test-retest repeatability
Measured: 30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
Measured: 30 days after participant's participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069143
- Sponsor's protocol ID
- IM033-002
- Status last verified
- Mar 2023
- First submitted
- 22 Aug 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04069143
- Acronym / sponsor ID
- IM033-002
- Keywords
- Healthy Participants, Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Diagnostic Test: 18F-BMS-986327 |
| Part 2 | Experimental | Diagnostic Test: 18F-BMS-986327 |
| Part 3 | Experimental | Diagnostic Test: 18F-BMS-986327 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index of 18.0 to 34.0 kg/m^2, inclusive, and body weight ≥ 50 kg
- 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
- Male and female participants aged 40 to 90 years
- Diagnosis of IPF less than 6 years before randomization
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-BMS-986327Imaging Agent | Diagnostic test | Part 1, Part 2, Part 3 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 3 days after participant's participation
Incidence of serious adverse events (SAEs)
Time frame: Up to 30 days after participant's participation
Radiation dosimetry calculated from positron emission tomography-computed tomography (PET-CT) images
Time frame: 30 days after participant's participation
Test-retest repeatability
Time frame: 30 days after participant's participation
Biodistribution and lung uptake calculated from PET-CT images in participants with IPF
Time frame: 30 days after participant's participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-BMS-986327 in people with Healthy Participants and Idiopathic Pulmonary Fibrosis (IPF), run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 3 days after participant's participation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.