A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood

Phase 1 Completed 19 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

Summary

The main objective of this trial is to investigate the possible effect of multiple oral doses of BI 425809 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (administered as the combined oral contraceptive Microgynon®).

Timeline

Start: 2022-11-24
Primary completion: 2023-10-04
Completion: 2023-10-04

Outcome

Met primary endpoint

paper geometric mean ratios for AUCτ,ss, Cmax,ss, and Cmin,ss were slightly above 100%, and 90% CIs were within standard bioequivalence boundaries (80-125%). PMID 40906309 ↗

Publications

Madari S, Balavarca Y, Shatillo Y, Reuteman-Fowler C, Desch M. The Effect of Multiple Oral Doses of a Glycine Transporter 1 Inhibitor, Iclepertin (BI 425809), on the Steady-state Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel: a Phase I Clinical Trial in Healthy Females. Clin Drug Investig. 2025 Oct;45(10):767-779. doi: 10.1007/s40261-025-01472-5. Epub 2025 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iclepertin	Unknown	10 mg	Oral
Subject	Levonorgestrel	Small molecule	150 ug	Oral
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

Indications

No indication recorded.