Open label, single-center, cross-over randomized, relative bioavailability study comparing 4 new BF2.649 (pitolisant) tablet formulations versus the reference pitolisant (Wakix®) tablet formulation after single oral administrations in healthy male subjects.

Start 26 Sep 2023 · End 3 Jan 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol P22-06

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 16

Countries 1

Sites 1

Narcolepsy

Key facts

Sponsor: Bioprojet Pharma
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trial duration: 26 Sep 2023 → 3 Jan 2024
Decision date (initial): 2023-08-17
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

Version	Level	Code	Term	System 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

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

Country	MS status	Planned subjects	Sites
Belgium	Ended	16	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ended

Advanced Technology Corporation

Clinical Pharmacology Unit, Avenue Hippocrate 15, 4000, Liege

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2023-09-26	2024-01-03	2023-09-26	2023-12-22

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-07-13	Belgium	Acceptable 2023-08-16	2023-08-17
2	SUBSTANTIAL MODIFICATION	SM-1	2023-08-17	Belgium	Acceptable	2023-09-01
3	SUBSTANTIAL MODIFICATION	SM-2	2023-09-26	Belgium	Acceptable	2023-10-10