Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women

Summary

The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.

Timeline

Start

2015-04

Primary completion

2015-12

Completion

2016-04

Publications

• Gashaw I, Reif S, Wiesinger H, Kaiser A, Zollmann FS, Scheerans C, Grevel J, Piraino P, Seidel H, Peters M, Rottmann A, Rohde B, Arlt W, Hilpert J. Novel aldo-keto reductase 1C3 inhibitor affects androgen metabolism but not ovarian function in healthy women: a phase 1 study. Eur J Endocrinol. 2023 Jul 10;188(7):578-591. doi: 10.1093/ejendo/lvad063.

Drugs

Indications