Clinical trial NCT05065541: Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CC-97489
Healthy Adults
Phase 1
Positron Emission Tomography (PET) Imaging
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Radiation dosimetry calculated from PET-CT images
timeFrame: 1 day
measure: Calculated % Injected Dose in brain and other key organs and tissues
timeFrame: 1 day
measure: Calculated Standard Uptake Volume in brain and other key organs and tissues
timeFrame: 1 day
measure: Change from baseline in SUV in the brain based on PET scans
timeFrame: Up to 14 days
measure: Change from baseline in VT in the brain based on PET scans.
timeFrame: Up to 14 days
Secondary outcomes:
measure: Incidence of AEs
timeFrame: Up to 28 days after the last dose
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 28 days after the last dose
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Day 21
measure: Incidence of clinically significant changes in ECG parameters: QRS interval
timeFrame: Day 21
measure: Incidence of clinically significant changes in ECG parameters: QT interval
timeFrame: Day 21
measure: Incidence of clinically significant changes in ECG parameters: QTcF interval
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Day 21
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to Day 18
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to Day 18
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to Day 18
measure: Pharmacokinetics - Maximum observed plasma concentration (Cmax)
timeFrame: Up to 19 days
measure: Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to 19 days
measure: Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
timeFrame: Up to 19 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Local Institution - 001
state: Vlaams Brabant
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: