A Phase I, Open-Label, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Influence of a High-Calorie, High-Fat Meal on the Bioavailability of a 40 mg Extended-Release (XR) Deucrictibant Oral Formulation Administered as a Single Dose.

Start 30 Dec 2024 · End 19 Feb 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol PHA022121-C021

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 18

Countries 1

Sites 1

Hereditary angioedema (HAE)

Key facts

Sponsor: Pharvaris Netherlands B.V.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trial duration: 30 Dec 2024 → 19 Feb 2025
Decision date (initial): 2024-11-15
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Hereditary angioedema (HAE)

Version	Level	Code	Term	System organ class
23.1	PT	10019860	Hereditary angioedema	100000004850

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pharvaris Netherlands B.V.

Sponsor organisation: Pharvaris Netherlands B.V.
Address: J.H. Oortweg 21
City: Leiden
Postcode: 2333 CH
Country: Netherlands

Scientific contact point

Organisation: Pharvaris Netherlands B.V.
Contact name: Rafael Crabbé

Public contact point

Organisation: Pharvaris Netherlands B.V.
Contact name: Rafael Crabbé

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Hungary	Ended	18	1
Rest of world	—	0	—

Investigational sites

Hungary

1 site · Ended

Pharmaceutical Research Associates Magyarorszag

PRA Klinikai Farmakológiai Vizsgálóhely, Rottenbiller Utca 13, 1077, Budapest

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
Hungary	2024-12-30	2025-02-19	2024-12-30	2025-01-28

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-22	Hungary	Acceptable 2024-11-14	2024-11-15