Clinical trial • Phase I • Neurology
BP1.15205 for Narcolepsy
Phase I trial of BP1.15205 for Narcolepsy. Randomised, placebo (matching bp1.15205); dose and schedule not specified-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Narcolepsy
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 03-09-2025
- First CTIS Authorization Date
- 10-10-2025
Trial design
Randomised, placebo (matching bp1.15205); dose and schedule not specified-controlled, adaptive Phase I trial in Belgium.
- Randomised
- Yes
- Comparator
- Placebo (matching BP1.15205); dose and schedule not specified
- Adaptive
- True - single and repeated oral ascending doses (dose escalation); no detailed escalation rules, interim analyses or stopping rules provided in the available documents
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 178
Recruitment
- Planned Sample Size
- 178
- Recruitment Window Months
- 18
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 178
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-09-2025
- Latest Decision Or Authorization Date
- 10-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 178
Sites
- Site Name
- Inokura - Avenue De L'Hopital 1
- Department Name
- CLINICAL PHARMACOLOGY UNIT
- Contact Person Name
- Xaviere RAUSIN
- Contact Person Email
- xaviere.rausin@inokura.be
Sponsor
Primary sponsor
- Full Name
- Bioprojet Pharma
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- BP1.15205
- Routes Of Administration
- oral
- Route
- oral
- First In Human
- Yes
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