ImmunologyPhase 1NCT02017730
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers
A Phase 1 study testing BMS-986020 and [11C]BMT-136088 in people with Immunology, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of a novel positron emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immunology
- What is being tested?
- BMS-986020 and [11C]BMT-136088
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m2, inclusive
- Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests
- Negative hepatitis panel and negative human immunodeficiency virus (HIV)antibody screens
Who cannot join
- Any history or presence of clinically significant respiratory, Gastro Intestinal (GI), renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers
- Any acute or chronic condition that, in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of the BMS-986020
- Any major surgery within 4 weeks of study drug administration
- Existence of a cold, upper respiratory tract infection, or fever within 5 days prior to check-in
- Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism or elimination of the study drug
- Donation of blood or plasma (exclude the screening visit) within 2 months prior to check in through end of synthesis (EOS), inclusive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study To Evaluate The Safety and Tolerability Of A Novel LPA1 Receptor Positron Emission Tomography (PET) Ligand [11C]BMT-136088 And To Assess Receptor Occupancy In Human Lung Following Oral Administration Of BMS-986020 In Healthy Subjects
The purpose of this study is to assess the safety and tolerability of a novel positron emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following oral administration of Bristol Myers Squibb (BMS)-986020.
Read the detailed description
End point Classification: Pharmacokinetics/Pharmacodynamics
- Conditions
- Immunology
- Being tested
- BMS-986020, [11C]BMT-136088
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986020Drug
[11C]BMT-136088Drug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: [11C]BMT-136088 (Safety Study) | Experimental | Single PET SCAN with single bolus injection of [11C]BMT-136088 Receives: Drug: [11C]BMT-136088 |
| Part 2: [11C]BMT-136088 (Test/Retest study) | Experimental | Single PET SCAN with Intravenous (IV) bolus plus infusion of [11C]BMT-136088 followed by a re-test PET scan (approximately 6 hours apart) with IV bolus plus infusion of [11C]BMT-136088 Receives: Drug: [11C]BMT-136088 |
| Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study) | Experimental | BMS-986020 Tablets or Oral Solution of 4 dose levels from from the 6 dose levels of (50 mg, 150 mg, 300 mg, 600 mg, 1200 mg and 1500 mg) and 3 PET SCANS (Pre-Dose, Post-Dose1, Post-Dose2) with bolus plus infusion of [11C]BMT-136088 Receives: Drug: BMS-986020; Drug: [11C]BMT-136088 |
| Part 4: [11C]BMT-136088 (Tissue Distribution study) | Experimental | Single PET SCAN with [11C]BMT-136088 to evaluate additional tracer uptake sites in humans other than the lung, such as heart, kidney, liver, gallbladder, etc. Receives: Drug: [11C]BMT-136088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall safety and tolerability of novel tracer [11C]BMT-136088
The following safety endpoints will be considered, the incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation from the study, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations occurring from screening up to study discharge.
Measured: Approximately up to 90 days
Lung LPA1 percentage receptor occupancy of BMS-986020
Assessed by [11C]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020.
Measured: Up to 2 days post BMS-986020 administration
Secondary outcomes (7)
Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration.
Measured: Up to 48 hr postdose (Approximately up to Day 3)
Maximum observed concentration (Cmax) of BMS-986020
Measured: 13 timepoints up to Day 3
Time of maximum observed concentration (Tmax) of BMS-986020
Measured: 13 timepoints up to Day 3
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020
Measured: 13 timepoints up to Day 3
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020
Measured: 13 timepoints up to Day 3
Half life (T-HALF) of BMS-986020
Measured: 13 timepoints up to Day 3
Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects
Safety based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations
Measured: Approximately up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunologyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02017730
- Sponsor's protocol ID
- IM136-106
- Status last verified
- Jul 2015
- First submitted
- 17 Dec 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study To Evaluate The Safety and Tolerability Of A Novel LPA1 Receptor Positron Emission Tomography (PET) Ligand [11C]BMT-136088 And To Assess Receptor Occupancy In Human Lung Following Oral Administration Of BMS-986020 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02017730
- Acronym / sponsor ID
- IM136-106
- Conditions
- Immunology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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 and tolerability of a novel positron emission tomography (PET) tracer [11C]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using [11C]BMT-136088 in the human lung following oral administration of Bristol Myers Squibb (BMS)-986020.
Detailed description
End point Classification: Pharmacokinetics/Pharmacodynamics
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: [11C]BMT-136088 (Safety Study) | Experimental | Drug: [11C]BMT-136088Single PET SCAN with single bolus injection of [11C]BMT-136088 |
| Part 2: [11C]BMT-136088 (Test/Retest study) | Experimental | Drug: [11C]BMT-136088Single PET SCAN with Intravenous (IV) bolus plus infusion of [11C]BMT-136088 followed by a re-test PET scan (approximately 6 hours apart) with IV bolus plus infusion of [11C]BMT-136088 |
| Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study) | Experimental | Drug: BMS-986020, Drug: [11C]BMT-136088BMS-986020 Tablets or Oral Solution of 4 dose levels from from the 6 dose levels of (50 mg, 150 mg, 300 mg, 600 mg, 1200 mg and 1500 mg) and 3 PET SCANS (Pre-Dose, Post-Dose1, Post-Dose2) with bolus plus infusion of [11C]BMT-136088 |
| Part 4: [11C]BMT-136088 (Tissue Distribution study) | Experimental | Drug: [11C]BMT-136088Single PET SCAN with [11C]BMT-136088 to evaluate additional tracer uptake sites in humans other than the lung, such as heart, kidney, liver, gallbladder, etc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m2, inclusive
- Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests
- Negative hepatitis panel and negative human immunodeficiency virus (HIV)antibody screens
Key exclusion criteria (6 listed)
- Any history or presence of clinically significant respiratory, Gastro Intestinal (GI), renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers
- Any acute or chronic condition that, in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of the BMS-986020
- Any major surgery within 4 weeks of study drug administration
- Existence of a cold, upper respiratory tract infection, or fever within 5 days prior to check-in
- Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism or elimination of the study drug
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 |
|---|---|---|
| BMS-986020 | Drug | Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study) |
| [11C]BMT-136088 | Drug | Part 1: [11C]BMT-136088 (Safety Study), Part 2: [11C]BMT-136088 (Test/Retest study), Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study), Part 4: [11C]BMT-136088 (Tissue Distribution study) |
Primary outcome
Overall safety and tolerability of novel tracer [11C]BMT-136088
Time frame: Approximately up to 90 days
The following safety endpoints will be considered, the incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation from the study, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations occurring from screening up to study discharge.
Lung LPA1 percentage receptor occupancy of BMS-986020
Time frame: Up to 2 days post BMS-986020 administration
Assessed by [11C]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020.
7 secondary outcomes
Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration.
Time frame: Up to 48 hr postdose (Approximately up to Day 3)
Maximum observed concentration (Cmax) of BMS-986020
Time frame: 13 timepoints up to Day 3
Time of maximum observed concentration (Tmax) of BMS-986020
Time frame: 13 timepoints up to Day 3
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020
Time frame: 13 timepoints up to Day 3
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020
Time frame: 13 timepoints up to Day 3
Half life (T-HALF) of BMS-986020
Time frame: 13 timepoints up to Day 3
Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects
Time frame: Approximately up to 90 days
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 Jul 2015.
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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 BMS-986020 and [11C]BMT-136088 in people with Immunology, 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 3 inclusion and 6 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 Jul 2015. 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?
Overall safety and tolerability of novel tracer [11C]BMT-136088 (time frame: Approximately up to 90 days). The study lists 2 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 Jul 2015.