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

NCT ID: NCT05065541

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-24

Study Completion Date

2024-01-29

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

[18F]T-401

Intervention Type DRUG

Specified dose on specified days

Part 2

Group Type EXPERIMENTAL

CC-97489

Intervention Type DRUG

Specified dose on specified days

[18F]T-401

Intervention Type DRUG

Specified dose on specified days

[11C]MK-3168

Intervention Type DRUG

Specified dose on specified days

Part 3

Group Type EXPERIMENTAL

CC-97489

Intervention Type DRUG

Specified dose on specified days

[18F]T-401

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-97489

Specified dose on specified days

Intervention Type DRUG

[18F]T-401

Specified dose on specified days

Intervention Type DRUG

[11C]MK-3168

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 001

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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2021-000646-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-97489-CP-002

Identifier Type: -

Identifier Source: org_study_id

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