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
2 other identifiers
interventional
32
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Sep 2021
Longer than P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2021
CompletedStudy Start
First participant enrolled
September 24, 2021
CompletedFirst Posted
Study publicly available on registry
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2024
CompletedFebruary 16, 2024
February 1, 2024
2.3 years
September 23, 2021
February 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (16)
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
Day 21
Incidence of clinically significant changes in ECG parameters: QRS interval
Day 21
Incidence of clinically significant changes in ECG parameters: QT interval
Day 21
- +11 more secondary outcomes
Study Arms (3)
Part 1
EXPERIMENTALPart 2
EXPERIMENTALPart 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (1)
Local Institution - 001
Leuven, Vlaams Brabant, 3000, Belgium
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2021
First Posted
October 4, 2021
Study Start
September 24, 2021
Primary Completion
January 29, 2024
Study Completion
January 29, 2024
Last Updated
February 16, 2024
Record last verified: 2024-02