Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05065541
- Lead Sponsor
- Celgene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2 [11C]MK-3168 - Part 3 CC-97489 - Part 2 [18F]T-401 - Part 2 CC-97489 - Part 1 [18F]T-401 - Part 3 [18F]T-401 -
- Primary Outcome Measures
Name Time Method Calculated Standard Uptake Volume in brain and other key organs and tissues 1 day Radiation dosimetry calculated from PET-CT images 1 day Calculated % Injected Dose in brain and other key organs and tissues 1 day Change from baseline in VT in the brain based on PET scans. Up to 14 days Change from baseline in SUV in the brain based on PET scans Up to 14 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics - Maximum observed plasma concentration (Cmax) Up to 19 days Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) Up to 19 days Incidence of AEs Up to 28 days after the last dose 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 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 - Time to maximum observed plasma concentration (Tmax) Up to 19 days Incidence of clinically significant changes in ECG parameters: QTcF interval Day 21 QTcF interval: Corrected QT interval using Fridericia's formula (QTcF).
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to Day 18 Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Day 21 PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in ECG parameters: QRS interval Day 21 QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization.
Incidence of clinically significant changes in ECG parameters: QT interval Day 21 QT interval: Measured from the beginning of the QRS complex to the end of the T wave.
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 serious adverse events (SAEs) Up to 28 days after the last dose
Trial Locations
- Locations (1)
Local Institution - 001
🇧🇪Leuven, Vlaams Brabant, Belgium