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

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CC-97489; Drug: [11C]MK-3168; Drug: [18F]T-401

Study type: Interventional

Funder types: Industry

Identifiers

NCT05065541

2021-000646-17 (EudraCT Number)

CC-97489-CP-002

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Part 1

Experimental group

Treatment:

Drug: [18F]T-401

Part 2

Experimental group

Treatment:

Drug: [18F]T-401

Drug: CC-97489

Drug: [11C]MK-3168

Part 3

Experimental group

Treatment:

Drug: [18F]T-401

Drug: CC-97489