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Completed

NCT Number: NCT05065541

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 001

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-97489

Drug

Specified dose on specified days

[18F]T-401

Drug

Specified dose on specified days

[11C]MK-3168

Drug

Specified dose on specified days

Primary outcomes

  1. Radiation dosimetry calculated from PET-CT images

    Time frame: 1 day

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

    Time frame: 1 day

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

    Time frame: 1 day

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

    Time frame: Up to 14 days

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

    Time frame: Up to 14 days

Secondary outcomes

  1. Incidence of AEs

    Time frame: Up to 28 days after the last dose

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 28 days after the last dose

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

    Time frame: Day 21

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

  4. Incidence of clinically significant changes in ECG parameters: QRS interval

    Time frame: Day 21

    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization.

  5. Incidence of clinically significant changes in ECG parameters: QT interval

    Time frame: Day 21

    QT interval: Measured from the beginning of the QRS complex to the end of the T wave.

  6. Incidence of clinically significant changes in ECG parameters: QTcF interval

    Time frame: Day 21

    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF).

  7. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Day 21

  8. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Day 21

  9. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Day 21

  10. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Day 21

  11. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to Day 18

  12. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to Day 18

  13. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to Day 18

  14. Pharmacokinetics - Maximum observed plasma concentration (Cmax)

    Time frame: Up to 19 days

  15. Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)

    Time frame: Up to 19 days

  16. Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

    Time frame: Up to 19 days

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Open-label, Multi-part Positron Emission Tomography (PET) Imaging Study to Evaluate the Biodistribution and Radiation Dosimetry of the Monoacylglycerol Lipase (MGLL) PET Ligand [18F]T-401 and to Evaluate Fatty Acid Amide Hydrolase (FAAH) and MGLL Enzyme Availability in the Central Nervous System Using [11C]MK-3168 and [18F]T-401 PET Ligands Before and After Oral Administration of Single and Multiple Doses of CC-97489 in Healthy Adult Subjects

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2021
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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