Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants

Celgene32 enrolled

Overview

The purpose of this study is to evaluate enzyme availability in the central nervous system before and after CC-97489 administration in healthy participants

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

CC-97489DRUG

Specified dose on specified days

[18F]T-401DRUG

Specified dose on specified days

[11C]MK-3168DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 001

Leuven, Vlaams Brabant, Belgium

Outcomes

Primary Outcomes

Radiation dosimetry calculated from PET-CT images

Time frame: 1 day

Calculated % Injected Dose in brain and other key organs and tissues

Time frame: 1 day

Calculated Standard Uptake Volume in brain and other key organs and tissues

Time frame: 1 day

Change from baseline in SUV in the brain based on PET scans

Time frame: Up to 14 days

Change from baseline in VT in the brain based on PET scans.

Time frame: Up to 14 days

Secondary Outcomes

Incidence of AEs

Time frame: Up to 28 days after the last dose

Incidence of serious adverse events (SAEs)

Time frame: Up to 28 days after the last dose

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

PR interval: The time from the onset of the P wave to the start of the QRS complex

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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