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, 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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CC-97489; Drug: [18F]T-401; Drug: [11C]MK-3168

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Local Institution - 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 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 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 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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Phase 1; Healthy Adults; CC-97489; Positron Emission Tomography (PET) Imaging
• Other Study ID Numbers: CC-97489-CP-002; 2021-000646-17 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No