Document is current
Any future updates will be listed below
-
Authors
Aslanis, Vassilios https://orcid.org/0000-0003-0997-0081
Gray, Michael
Slack, Robert J. https://orcid.org/0000-0002-4372-9438
Zetterberg, Fredrik R. https://orcid.org/0000-0002-7789-8782
Tonev, Dimitar
Phung, De
Smith, Becky
Jacoby, Brian
Schambye, Hans
Krastev, Zahari
Ungell, Anna-Lena
Lindmark, Bertil
-
Clinical Trials BETA
Clinical trials referenced in this document:
nct05009680 at ClinicalTrials.govDocuments that mention this clinical trial
Single‑Dose Pharmacokinetics and Safety of the Oral Galectin‑3 Inhibitor, Selvigaltin (GB1211), in Participants with Hepatic Impairment
https://doi.org/10.1007/s40261-024-01395-7
-
Funding
Funding for this research was provided by:
Galecto Biotech AB
- License Information
-
More Information
Article History
Accepted: 15 September 2024
First Online: 2 October 2024
Declarations
:
: Galecto Biotech AB provided financial support for the study.
: A-LU, BJ, BS, BL, DP, DT, MG, RJS, VA: employees, personal fees–Galecto Biotech AB. FRZ, HS: employees, personal fees, patents (CA2,794,066, US13/832,672, WO/2014/067986)–Galecto Biotech AB. ZK: Principal Investigator, Comac Medical Ltd, Bulgaria, Company No 10317468.
: The study was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation and Good Clinical Practice. The initial protocol and other relevant study documents were approved by the Ethics Committee for Clinical Trials (ECCT, Sofia, Bulgaria) on July 20<sup>th</sup>, 2021 (approval letter Ref. No. EККИ/CT-0673/20.07.2021). Substantial Amendment 1 was approved by the ECCT on December 23<sup>rd</sup>, 2021 (approval letter Ref. No. EККИ/CT-1243/23.12.2021), and substantial Amendment 2 was approved by the ECCT on June 22<sup>nd</sup>, 2022 (approval letter Ref. No. EККИ/CT-0615/22.06.2022).
: Participants provided written informed consent.
: Not applicable.
: Research data are not shared.
: Not applicable.
: The authors met criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). All authors had full access to all study data and contributed to interpretation. All authors participated in writing the manuscript, with the support of medical writing services provided by the funder. All authors read and approved the submitted version of the manuscript.
