Healthy Volunteers
Conditions
Keywords
CC-97489, Healthy Adults, Phase 1, Positron Emission Tomography (PET) Imaging
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
Interventions
DRUGCC-97489
Specified dose on specified days
DRUG[18F]T-401
Specified dose on specified days
DRUG[11C]MK-3168
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | — |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to Day 18 | — |
| 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 | 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. |
Countries
Belgium
Outcome results
None listed