Phase 1Completed
A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives
A Single-center, Open-label, Fixed-sequence Trial to Investigate the Effect of Multiple-dose Aprocitentan on the Single-dose Pharmacokinetics of Combined Oral Contraceptives in Healthy Female Participants
- Sponsor
- Idorsia Pharmaceuticals Ltd. (Industry)
- Enrollment
- 19 enrolled
- Conditions
- Drug Drug Interaction
- Interventions
- Ethinyl Estradiol / Levonorgestrel Oral Tablet; Aprocitentan
- Ages
- adults, older adults
- Registry
- NCT06799884, CTIS2024-517224-19-00
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to learn if drug aprocitentan has an effect on hormonal contraceptives in healthy female volunteers. The main question it aims to answer is: Does aprocitentan modify the fate of hormonal contraceptives in the body? Trial participants will: * Take a single dose of hormonal contraceptives (fixed combination) alone * Take aprocitentan every day for 2 weeks * Take a single dose of the same hormonal contraceptives at the same time as the 10th administration of aprocitentan.
Primary outcomes
- Maximum plasma concentration (Cmax) of ethinyl estradiol/levonorgestrel
- Time to maximum plasma concentration (tmax) of ethinyl estradiol/levonorgestrel
- Area under the Plasma Concentration-Time Curve (AUC 0-t) of ethinyl estradiol/levonorgestrel
- Area under the Plasma Concentration-Time Curve (AUC 0-infinity) of ethinyl estradiol/levonorgestrel
History
Last registry update
Primary completion
Registered
Started