Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CC-97489
* Drug: [18F]T-401
* Drug: [11C]MK-3168


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br> | Drug: [18F]T-401<br>* Specified dose on specified days<br>|
| Experimental: Part 2<br> | Drug: CC-97489<br>* Specified dose on specified days<br>Drug: [18F]T-401<br>* Specified dose on specified days<br>Drug: [11C]MK-3168<br>* Specified dose on specified days<br>|
| Experimental: Part 3<br> | Drug: CC-97489<br>* Specified dose on specified days<br>Drug: [18F]T-401<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dosimetry calculated from PET-CT images |  | 1 day | 
| Calculated % Injected Dose in brain and other key organs and tissues |  | 1 day | 
| Calculated Standard Uptake Volume in brain and other key organs and tissues |  | 1 day | 
| Change from baseline in SUV in the brain based on PET scans |  | Up to 14 days | 
| Change from baseline in VT in the brain based on PET scans. |  | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs |  | Up to 28 days after the last dose | 
| Incidence of serious adverse events (SAEs) |  | 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 | 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. | 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. | Day 21 | 
| Incidence of clinically significant changes in ECG parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF). | Day 21 | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Day 21 | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Day 21 | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Day 21 | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Day 21 | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to Day 18 | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to Day 18 | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to Day 18 | 
| Pharmacokinetics - Maximum observed plasma concentration (Cmax) |  | Up to 19 days | 
| Pharmacokinetics - Time to maximum observed plasma concentration (Tmax) |  | Up to 19 days | 
| Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) |  | Up to 19 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CC-97489, Healthy Adults, Phase 1, Positron Emission Tomography (PET) Imaging