Trials / Completed
CompletedNCT04571996
Blood-Brain Barrier Penetration of Therapeutic Agents in Human
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ODM-104 | Capsule |
| DRUG | Paracetamol | Rapidly dissolving tablet |
Timeline
- Start date
- 2020-10-29
- Primary completion
- 2021-02-23
- Completion
- 2021-02-23
- First posted
- 2020-10-01
- Last updated
- 2021-04-13
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04571996. Inclusion in this directory is not an endorsement.