Tarral, Antoine http://orcid.org/0000-0003-1247-8653
Hovsepian, Lionel
Duvauchelle, Thierry
Donazzolo, Yves
Latreille, Mathilde
Felices, Mathieu
Gualano, Virginie
Delhomme, Sophie
Valverde Mordt, Olaf
Blesson, Severine
Voiriot, Pascal
Strub-Wourgaft, Nathalie
Clinical trials referenced in this document:
Documents that mention this clinical trial
Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study
https://doi.org/10.1007/s40262-023-01216-8
Funding for this research was provided by:
Bill and Melinda Gates Foundation (INV 002384)
Ministerie van Buitenlandse Zaken
Bundesministerium für Bildung und Forschung
Direktoratet for Utviklingssamarbeid
Article History
Accepted: 19 January 2023
First Online: 10 February 2023
Declarations
:
: See title page.
: VG and MF declare employment by PhinC Development, a CRO sub-contracted for this project. PV is CMO and President of Cardiabase, which provided central ECG services during the study. AT, SD, OV, SB, and NSW declare employment by study sponsor Drugs for Neglected Diseases <i>initiative.</i> YD declares employment by Eurofins Optimed. TD declares employment by SGS Aster at the time of the study. No other potential conflicts of interest were declared.
: The data underlying the results of this study are available upon request because they contain potentially sensitive information. Interested researchers may contact the Drugs for Neglected Diseases initiative (DNDi), commissioner of this study, for data access requests via email at CTdata@dndi.org. Researchers may also request data by completing the form available at ExternalRef removed. In this, they confirm that they will share data and results with DNDi and will publish any results open access.
: This study was conducted in accordance with the Declaration of Helsinki, French Huriet law (No. 2004-806), and Good Clinical Practice guidelines. The protocol and amendments were approved by the Committee of Protection of Persons (Paris, France) and by the national competent authority (Agence Nationale de Sécurité du Médicament).
: Written informed consent was obtained from all participants
: Not applicable
: Not applicable
: AT, OV, SD SB, NSW, TD, LH, and VG conceived and designed the experiments; LH, TD, ML, and YD performed the clinical studies; VG, MF and PV analysed the data and performed the statistical and pharmacokinetic analyses.