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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000646-17 | EudraCT Number |
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The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-97489 | Drug | Specified dose on specified days |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 001 | Leuven | Vlaams Brabant | 3000 | Belgium |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| [18F]T-401 |
| Drug |
Specified dose on specified days |
|
| [11C]MK-3168 | Drug | Specified dose on specified days |
|
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 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 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 |