Albendazole pharmacokinetics in plasma, intra-cystic fluid and cystic tissue of human cystic and alveolar echinococcosis

2024-518548-19-00 Human pharmacology (Phase I) - Other Ended

Start 27 Mar 2023 · End 6 Mar 2026 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 24
Countries 1
Sites 1

Human echinococcosis

Key facts

Sponsor
Medical University Of Vienna
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Parasitic Diseases [C03]
Trial duration
27 Mar 2023 → 6 Mar 2026
Decision date (initial)
2024-10-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518548-19-00
EudraCT number
2022-003581-20

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Human echinococcosis

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation
Medical University Of Vienna
Address
Spitalgasse 23, Alsergrund Alsergrund
City
Vienna
Postcode
1090
Country
Austria

Scientific contact point

Organisation
Medical University Of Vienna
Contact name
Department of Clinical Pharmacology

Public contact point

Organisation
Medical University Of Vienna
Contact name
Department of Clinical Pharmacology

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 24 1
Rest of world 0

Investigational sites

Austria

1 site · Ended
Medical University Of Vienna
Department of Clinical Pharmacology, Waehringer Guertel 18-20, Alsergrund, Vienna

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-03-27 2023-06-17 2025-12-12

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-10 Austria Acceptable
2024-10-24
2024-10-29