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 Change from baseline in VT in the brain based on PET scans. Up to 14 days Calculated % Injected Dose 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
- 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
Local Institution - 001🇧🇪Leuven, Vlaams Brabant, Belgium