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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Type 1 diabetes mellitus.
. 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.