CNS DiseasePhase 1BRIANNCT04571996
Blood-Brain Barrier Penetration of Therapeutic Agents in Human
A Phase 1 study testing ODM-104 and Paracetamol in people with CNS Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Disease
- What is being tested?
- ODM-104 and Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFinland
- Study dates
- 29 Oct 2020to 23 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Female participants of child-bearing potential and male participants with female partners of child-bearing potential must adhere to a highly effective form of contraception (listed in Section 4.6) from the first study treatment administration until 1 month after the EoS visit.
Who cannot join
- 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.
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- 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.
- Any clinically significant abnormalities in screening laboratory test results, vital signs or physical examination findings that might influence the results of the study or cause a health risk for the subject if he/she takes part in the study.
- Any clinically significant 12-lead ECG abnormality, such as QTcF > 450 ms, after 10 min rest in supine position at the screening visit.
- Heart rate (HR) < 50 bpm or > 90 bpm, systolic blood pressure (BP) < 90 mmHg or > 160 mmHg, or diastolic BP < 50 mmHg or > 100 mmHg in supine or seated position after 10 min rest at the screening visit.
- Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
- History of alcohol or drug abuse within the last 5 years, or current regular use of illicit drugs or excessive use of alcohol (regular alcohol drinking of more than 24 units/week for males or 14 units/week for females), or positive breath test for alcohol or positive urine test for drugs of abuse at screening or prior to the first IMP administration.
- Inability to refrain from consuming caffeine-containing beverages during the stay in the unit.
- Current use of nicotine-containing products, more than 5 cigarettes or equivalent/day, or inability to refrain from using nicotine-containing products during the stay at the study centre.
- Pregnant or lactating females.
- Participation in any other clinical drug study within 2 months before the first IMP administration of this study.
- Blood donation or loss of significant amount of blood within 2 months prior to the screening visit.
- Employee or first-degree relative of an employee of the contract research organization (CRST) or Orion.
- Any other condition that in the opinion of the investigator might interfere with the evaluation of the study results or constitute a health risk for the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood-Brain Barrier Penetration of Therapeutic Agents in Human - an Exploratory Repeated Dose Pharmacokinetic Study in Patients With Idiopathic Normal Pressure Hydrocephalus Treated With Cerebroventricular Shunting
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.
- Conditions
- CNS Disease
- Being tested
- ODM-104, Paracetamol
- Keywords
- Method, Blood Brain Barrier, Penetration, Therapeutics
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-104Drug
Capsule
ParacetamolDrug
Also called Panadol Zapp
Rapidly dissolving tablet
| Study group | Role | What they receive |
|---|---|---|
| ODM-104 and Panadol Zapp | Experimental | Not described Receives: Drug: ODM-104; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
In plasma / CSF
Measured: Daily PK samples during the first and last day of administration from day 1 to day 5-7
Tmax
In plasma / CSF
Measured: Daily PK samples during the first and last day of administration from day 1 to day 5-7
AUC
In plasma / CSF
Measured: Daily PK samples during the first and last day of administration from day 1 to day 5-7
Cav
In plasma / CSF
Measured: Daily PK samples during the first and last day of administration from day 1 to day 5-7
M/P ratio
In plasma / CSF
Measured: Daily PK samples during the first and last day of administration from day 1 to day 5-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start29 Oct 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Pharma Clinical study director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571996
- Sponsor's protocol ID
- 3112012
- Acronym
- BRIAN
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-Brain Barrier Penetration of Therapeutic Agents in Human - an Exploratory Repeated Dose Pharmacokinetic Study in Patients With Idiopathic Normal Pressure Hydrocephalus Treated With Cerebroventricular Shunting
- ClinicalTrials.gov ID
- NCT04571996
- Acronym / sponsor ID
- BRIAN / 3112012
- Conditions
- CNS Disease
- Keywords
- Method, Blood Brain Barrier, Penetration, Therapeutics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM-104 and Panadol Zapp | Experimental | Drug: ODM-104, Drug: Paracetamol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-104Capsule | Drug | ODM-104 and Panadol Zapp |
| ParacetamolAlso: Panadol ZappRapidly dissolving tablet | Drug | ODM-104 and Panadol Zapp |
Primary outcome
Cmax
Time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7
In plasma / CSF
Tmax
Time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7
In plasma / CSF
AUC
Time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7
In plasma / CSF
Cav
Time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7
In plasma / CSF
M/P ratio
Time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7
In plasma / CSF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orion Pharma Clinical study director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODM-104 and Paracetamol in people with CNS Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Daily PK samples during the first and last day of administration from day 1 to day 5-7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.