Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT05065541
  4. Details
NCT05065541 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05065541
Other study ID # CC-97489-CP-002
Secondary ID 2021-000646-17
Status Completed
Phase Phase 1
First received
Last updated
Start date September 24, 2021
Est. completion date January 29, 2024

Study information
Verified date February 2024
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 29, 2024
Est. primary completion date January 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CC-97489
Specified dose on specified days
• [18F]T-401
Specified dose on specified days
• [11C]MK-3168
Specified dose on specified days

Locations
Country Name City State
Belgium Local Institution - 001 Leuven Vlaams Brabant

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiation dosimetry calculated from PET-CT images 1 day
Primary Calculated % Injected Dose in brain and other key organs and tissues 1 day
Primary Calculated Standard Uptake Volume in brain and other key organs and tissues 1 day
Primary Change from baseline in SUV in the brain based on PET scans Up to 14 days
Primary Change from baseline in VT in the brain based on PET scans. Up to 14 days
Secondary Incidence of AEs Up to 28 days after the last dose
Secondary Incidence of serious adverse events (SAEs) Up to 28 days after the last dose
Secondary 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 Day 21
Secondary 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. Day 21
Secondary 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. Day 21
Secondary Incidence of clinically significant changes in ECG parameters: QTcF interval QTcF interval: Corrected QT interval using Fridericia's formula (QTcF). Day 21
Secondary Incidence of clinically significant changes in vital signs: Body temperature Day 21
Secondary Incidence of clinically significant changes in vital signs: Respiratory rate Day 21
Secondary Incidence of clinically significant changes in vital signs: Blood pressure Day 21
Secondary Incidence of clinically significant changes in vital signs: Heart rate Day 21
Secondary Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to Day 18
Secondary Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to Day 18
Secondary Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to Day 18
Secondary Pharmacokinetics - Maximum observed plasma concentration (Cmax) Up to 19 days
Secondary Pharmacokinetics - Time to maximum observed plasma concentration (Tmax) Up to 19 days
Secondary Pharmacokinetics - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-8) Up to 19 days
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1

External Links