Updates are available Correction dated 2024-03-05

Article History

Received: 20 October 2023

Accepted: 21 December 2023

First Online: 25 January 2024

Change Date: 5 March 2024

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s00280-024-04657-5

Declarations

:

: R Sechaud, G Rahmanzadeh, and H Menssen are employees of Novartis Pharma AG, Switzerland. H Gu, A Taylor, O Chiparus, are employees of Novartis Pharmaceuticals Corporation, USA. GK Sharma is an employee of Novartis Healthcare Pvt. Ltd., India. A Breitschaft is an employee of Parexel International GmbH, Germany.

: Both the studies were performed in accordance with the ethical principles, which have their origin in the Declaration of Helsinki and are consistent with Good Clinical Practice and applicable regulatory requirements. All participants of the study provided written informed consent according to international standards. Both studies were conducted at the Early Phase Clinical Unit of PAREXEL International GmbH in Berlin, Germany. The study protocols were reviewed and approved by the State Office of Health and Social Affairs Ethics Committee of Berlin (Landesamt für Gesundheitund Soziales Ethik-Kommission des Landes Berlin) for PAREXEL International GmbH. Study 1 with CYP substrates and Study 2 with oral contraceptives were registered under EudraCT number: 2018-002786-19 and EudraCT number: 2018-002867-25, respectively, and both obtained a favorable opinion from the IEC. The study participants were informed about the study procedures, risks, and benefits of their participation. Informed consent was documented by the investigator.