Blood-Brain Barrier Penetration of Therapeutic Agents in Human (NCT04571996) | Clinical Trial Compass
CompletedPhase 1
Blood-Brain Barrier Penetration of Therapeutic Agents in Human
Finland4 participantsStarted 2020-10-29
Plain-language summary
This is a phase 1, open-label, non-randomized, exploratory, repeated dose PK study performed at a single centre. Up to 6 evaluable subjects are planned. The subjects will receive p.o. doses of ODM-104 for 5-7 days. Single dose of paracetamol will be administered p.o. together with ODM-104 for purposes of comparison.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent (IC) obtained before any study assessments are performed.
✓. Sufficient command of the Finnish language to be able to understand the subject information and to communicate with the study personnel.
✓. Males and females over 18 years of age.
✓. Body mass index (BMI) between 18-30 kg/m2.
✓. Idiopathic normal pressure hydrocephalus.
✓. Shunt surgery with cerebroventricular catheter placed at least 3 months earlier.
✓. Good general health, based on medical history, physical examination and laboratory assessments.
✓. Adequate mental status to give informed consent as assessed by the investigator and using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery.
Exclusion criteria
✕. Predicted poor compliance with study procedures, restrictions and requirements.
✕. Vulnerable subjects (i.e. persons under any administrative or legal supervision).
✕. Veins unsuitable for repeated venipuncture or cannulation
✕. Evidence of other current clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolicendocrine, neurological, urogenital or psychiatric disease than iNPH, as judged by the investigator.
What they're measuring
1
Cmax
Timeframe: Daily PK samples during the first and last day of administration from day 1 to day 5-7
2
Tmax
Timeframe: Daily PK samples during the first and last day of administration from day 1 to day 5-7
3
AUC
Timeframe: Daily PK samples during the first and last day of administration from day 1 to day 5-7
4
Cav
Timeframe: Daily PK samples during the first and last day of administration from day 1 to day 5-7
5
M/P ratio
Timeframe: Daily PK samples during the first and last day of administration from day 1 to day 5-7
✕. Diagnosis of cancer for which the subject is currently being treated, or for which there is evidence of active disease. Subjects with local prostate cancer or local dermatological tumours, such as basal or squamous cell carcinoma, may be included.
✕. Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock due to any reason.
✕. Use of medications impacting the metabolism of dopamine, such as other COMT inhibitors (e.g. entacapone), levodopa and monoamine oxidase (MAO) inhibitors (e.g. rasagiline, selegiline), within 4 weeks before the first study drug administration.