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CC-97489

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 16, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

CC-97489 · 1 trial · 1 indication

Phase 1 1
NCT05065541Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy ParticipantsHealthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
Positron Emission Tomography (PET) Imaging Study to Evaluate Enzyme Availability in the Central Nervous System Before and After CC-97489 Administration in Healthy Participants
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Study Endpoints

Primary Endpoints

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 Endpoints

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
Day 21
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Part 3EXPERIMENTAL -

Interventions

NameTypeDescription
CC-97489DRUGSpecified dose on specified days
[18F]T-401DRUGSpecified dose on specified days
[11C]MK-3168DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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-...

Countries:Belgium
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Frequently asked questions about CC-97489

What is CC-97489 used for?

CC-97489 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial that evaluated its effects on enzyme availability in the central nervous system using positron emission tomography (PET) imaging.

Who makes CC-97489?

CC-97489 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this investigational small molecule.

What phase is CC-97489 in?

CC-97489 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. Its Phase 1 trial has been completed, and it is not currently in active clinical trials.

What clinical trials is CC-97489 in?

CC-97489 has one completed Phase 1 trial, NCT05065541, which enrolled 32 healthy participants in Belgium. The study used PET imaging to evaluate enzyme availability in the central nervous system before and after CC-97489 administration.

Is CC-97489 FDA approved?

CC-97489 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The completed trial in healthy volunteers was a controlled study, but the drug has not yet progressed to later-stage trials or regulatory approval.