Healthy VolunteersPhase 1NCT05065541
Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants
A Phase 1 study testing CC-97489, [18F]T-401 and [11C]MK-3168 in people with Healthy Volunteers, run by Celgene at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-97489, [18F]T-401 and [11C]MK-3168
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Sep 2021to 29 Jan 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a Body Mass Index (BMI) of 18.0 to 33.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
- Must be healthy based on medical history, physical examination (PE), clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-in
Who cannot join
- Has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Is pregnant or breastfeeding
- Is part of the study site staff personnel or a family member of the study site staff
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Multi-part Positron Emission Tomography (PET) Imaging Study to Evaluate the Biodistribution and Radiation Dosimetry of the Monoacylglycerol Lipase (MGLL) PET Ligand [18F]T-401 and to Evaluate Fatty Acid Amide Hydrolase (FAAH) and MGLL Enzyme Availability in the Central Nervous System Using [11C]MK-3168 and [18F]T-401 PET Ligands Before and After Oral Administration of Single and Multiple Doses of CC-97489 in Healthy Adult Subjects
The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants
- Conditions
- Healthy Volunteers
- Being tested
- CC-97489, [18F]T-401, [11C]MK-3168
- Keywords
- CC-97489, Healthy Adults, Phase 1, Positron Emission Tomography (PET) Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-97489Drug
Specified dose on specified days
[18F]T-401Drug
Specified dose on specified days
[11C]MK-3168Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: [18F]T-401 |
| Part 2 | Experimental | Not described Receives: Drug: CC-97489; Drug: [18F]T-401; Drug: [11C]MK-3168 |
| Part 3 | Experimental | Not described Receives: Drug: CC-97489; Drug: [18F]T-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dosimetry calculated from PET-CT images
Measured: 1 day
Calculated % Injected Dose in brain and other key organs and tissues
Measured: 1 day
Calculated Standard Uptake Volume in brain and other key organs and tissues
Measured: 1 day
Change from baseline in SUV in the brain based on PET scans
Measured: Up to 14 days
Change from baseline in VT in the brain based on PET scans.
Measured: Up to 14 days
Secondary outcomes (16)
Incidence of AEs
Measured: Up to 28 days after the last dose
Incidence of serious adverse events (SAEs)
Measured: Up to 28 days after the last dose
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Measured: Day 21
Incidence of clinically significant changes in ECG parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization.
Measured: Day 21
Incidence of clinically significant changes in ECG parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave.
Measured: Day 21
Incidence of clinically significant changes in ECG parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF).
Measured: Day 21
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Day 21
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Day 21
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Day 21
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Day 21
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to Day 18
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to Day 18
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to Day 18
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Measured: Up to 19 days
Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)
Measured: Up to 19 days
Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: Up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start24 Sep 2021
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- 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
- NCT05065541
- Sponsor's protocol ID
- CC-97489-CP-002
- Other IDs
- 2021-000646-17
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-part Positron Emission Tomography (PET) Imaging Study to Evaluate the Biodistribution and Radiation Dosimetry of the Monoacylglycerol Lipase (MGLL) PET Ligand [18F]T-401 and to Evaluate Fatty Acid Amide Hydrolase (FAAH) and MGLL Enzyme Availability in the Central Nervous System Using [11C]MK-3168 and [18F]T-401 PET Ligands Before and After Oral Administration of Single and Multiple Doses of CC-97489 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05065541
- Acronym / sponsor ID
- CC-97489-CP-002
- Conditions
- Healthy Volunteers
- Keywords
- CC-97489, Healthy Adults, Phase 1, Positron Emission Tomography (PET) Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 4 Oct 2021 (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 evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: [18F]T-401 |
| Part 2 | Experimental | Drug: CC-97489, Drug: [18F]T-401, Drug: [11C]MK-3168 |
| Part 3 | Experimental | Drug: CC-97489, Drug: [18F]T-401 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has a Body Mass Index (BMI) of 18.0 to 33.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
- Must be healthy based on medical history, physical examination (PE), clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) at screening and check-in
Key exclusion criteria (4 listed)
- Has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Is pregnant or breastfeeding
- Is part of the study site staff personnel or a family member of the study site staff
- Other protocol-defined inclusion/exclusion 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 |
|---|---|---|
| CC-97489Specified dose on specified days | Drug | Part 2, Part 3 |
| [18F]T-401Specified dose on specified days | Drug | Part 1, Part 2, Part 3 |
| [11C]MK-3168Specified dose on specified days | Drug | Part 2 |
Primary outcome
Radiation dosimetry calculated from PET-CT images
Time frame: 1 day
Calculated % Injected Dose in brain and other key organs and tissues
Time frame: 1 day
Calculated Standard Uptake Volume in brain and other key organs and tissues
Time frame: 1 day
Change from baseline in SUV in the brain based on PET scans
Time frame: Up to 14 days
Change from baseline in VT in the brain based on PET scans.
Time frame: Up to 14 days
16 secondary outcomes
Incidence of AEs
Time frame: Up to 28 days after the last dose
Incidence of serious adverse events (SAEs)
Time frame: Up to 28 days after the last dose
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Day 21
Incidence of clinically significant changes in ECG parameters: QRS interval
Time frame: Day 21
Incidence of clinically significant changes in ECG parameters: QT interval
Time frame: Day 21
Incidence of clinically significant changes in ECG parameters: QTcF interval
Time frame: Day 21
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Day 21
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Day 21
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Day 21
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Day 21
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to Day 18
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to Day 18
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to Day 18
Pharmacokinetics - Maximum observed plasma concentration (Cmax)
Time frame: Up to 19 days
Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)
Time frame: Up to 19 days
Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Up to 19 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 16 Feb 2024.
- BMS Clinical Trial InformationLink 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 CC-97489, [18F]T-401 and [11C]MK-3168 in people with Healthy Volunteers, run by Celgene at 1 site in Belgium.
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 2 inclusion and 4 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 16 Feb 2024. 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 Belgium. 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?
Radiation dosimetry calculated from PET-CT images (time frame: 1 day). 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 16 Feb 2024.