Huntington Disease Clinical Trial
Official title:
Biodistribution and Dosimetry in Human Healthy Volunteers of the Novel PET Radioligands [11C]CHDI-00485180-R and [11C]CHDI-00485626, Designed for Quantification of Cerebral Aggregated Mutant Huntingtin in Huntington's Disease.
NCT number | NCT05224115 |
Other study ID # | s64086 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 17, 2020 |
Est. completion date | October 13, 2020 |
Verified date | May 2022 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A better understanding of the HD pathogenesis mechanisms may lead to a better understanding of disease pathology, progression and development of targeted therapies. [11C]CHDI-00485180-R and [11C]CHDI-00485626 are two novel mutant huntingtin aggregate binding PET radioligands which have already demonstrated sensitivity to mutant huntingtin load in animal models. In the current study, the biodistribution and dosimetry of both these ligands will be investigated in young healthy volunteers according to a standard approach, in 3 subjects (including both genders) per tracer.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 13, 2020 |
Est. primary completion date | October 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Male or female subjects, age between 18 and 55 years old - Subject is judged to be in good health by the investigator on the basis of medical history. When still in doubt, a full physical and neurological examination can be conducted Exclusion Criteria: - Subject has a history of major internal disease that may interfere with the investigations (especially liver and kidney disease, cancer or uncontrolled diabetes). - Subject has any history of a major neurological or psychiatric disorder - Subject is currently smoker (> 20 cigarettes or equivalent/day) a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse. - Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months. - Subject suffers from claustrophobia or cannot tolerate confinement during PET-CT scanning procedures; subject cannot lie still for 90 minutes inside the scanner. - Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) 3 days before and during the day of scanning. - Subject does not understand the study procedure - Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator. - Subject is potentially pregnant (hCG will be performed in women with childbearing potential). - Allergy for local anesthesia (lidocaine) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | CHDI Foundation, Inc. |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normalized cumulated activity coefficients (NCA) | Normalized cumulated activity coefficients (MBq-hr/hr) for indicated source organs determined from whole-body imaging. | Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes) | |
Primary | Total organ doses | Total organ doses (µGy/MBq) for indicated target organs. | Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes) | |
Primary | Effective doses (ED) | Effective doses (µSv/MBq) for indicated target organs. | Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes) |
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