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Randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of pitolisant after repeated oral ascending doses for 14 days, including the pitolisant effect on cardiac repolarization in healthy volunteers.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503945-78-00
Acronym
BF2.649/P22-08
Enrollment
75
Registered
2023-06-13
Start date
2023-06-13
Completion date
2024-07-24
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, Narcolepsy with cataplexy

Interventions

None listed

Sponsors

Bioprojet Pharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026