Open label, single-center, four-part registration pharmacokinetic study: Part I: Pilot 2-way cross-over randomized, comparative pharmacokinetic study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after a single 20 mg oral administration in twelve healthy subjects, in order to evaluate the adequate sample size to demonstrate the bioequivalence. Part II: One sequence cross-over, drug-drug interaction pharmacokinetic study between a proton pump inhibitor (PPI) (pantoprazole 40 mg) and a new gastro-resistant 20 mg pitolisant hydrochloride formulation in eighteen healthy subjects. Part III: Pivotal 4-way replicate design cross-over randomized, bioequivalence study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation versus the reference formulation, after single oral 20 mg administration in healthy subjects. Part IV: 2-way cross-over randomized, food effect study of a new gastro-resistant 20 mg pitolisant hydrochloride formulation administered under fasting conditions and after a standard FDA High Fat Breakfast in eighteen healthy subjects.

2023-507316-12-00 Protocol P22-12 Human pharmacology (Phase I) - Other Ended

Start 20 Oct 2023 · End 6 Oct 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol P22-12

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 104
Countries 1
Sites 1

Narcolepsy with cataplexy

Key facts

Sponsor
Bioprojet Pharma
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
20 Oct 2023 → 6 Oct 2025
Decision date (initial)
2023-10-10
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Narcolepsy with cataplexy

VersionLevelCodeTermSystem organ class
20.0 PT 10028713 Narcolepsy 100000004852
20.0 LLT 10028715 Narcolepsy with cataplexy 10029205

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioprojet Pharma

17 Total trials 6 Recruiting 11 Ended
Commercial
Sponsor organisation
Bioprojet Pharma
Address
9 Rue Rameau
City
Paris
Postcode
75002
Country
France

Scientific contact point

Organisation
Bioprojet Pharma
Contact name
Clinical Development Director

Public contact point

Organisation
Bioprojet Pharma
Contact name
Clinical Development Director

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ended 104 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ended
Advanced Technology Corporation
Clinical Pharmacology Unit, Avenue De L'hopital 1, Etage 2e Tour 2 Route 124, Liege

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-10-20 2025-10-06 2023-10-20 2025-10-06

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-25 Belgium Acceptable
2023-10-05
 2023-10-10
2 SUBSTANTIAL MODIFICATION SM-1 2024-08-27 Belgium Acceptable
2024-10-01
 2024-10-01
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-03-12 Belgium Acceptable
2024-10-01
 2025-03-12
4 NON SUBSTANTIAL MODIFICATION NSM-2 2025-06-03 Belgium Acceptable
2024-10-01
 2025-06-03

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