NCT06799884

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The main objective of the trial is to evaluate the influence of aprocitentan at steady-state on the single-dose pharmacokinetics (PK) of combined oral contraceptives. 19 healthy female participants will be enrolled to have at least 16 evaluable participants. Following a screening period (from full signature of the informed consent form \[ICF\] to enrollment; 10 to 28 days prior to first trial intervention administration), eligible participants (meeting all inclusion criteria and none of the exclusion criteria) will be enrolled in the trial to participate in two sequential trial periods, Trial Period A and Trial Period B, with an in-between period of at least 7 days. Trial Period B will be split into two sequential sub-periods, Trial Period B1 and Trial Period B2. * Trial Period A: Starts with a single administration of trial intervention on Day 1 and ends with an End-of-Trial Period (EoTP) assessment on Day 5. Trial intervention administration on Day 1 will be followed by a 96-hour observation period for safety monitoring and PK sampling. * Trial Period B1: Trial intervention will be administered from Day 1 to Day 9, with assessments for PK sampling and safety monitoring performed throughout. * Trial Period B2: Starts with administration of trial intervention on Day 10 and ends with an EoTP assessment on Day 14. Trial intervention will be administered from Day 10 to Day 13, with assessments for PK sampling and safety monitoring performed throughout. Trial participation of an individual participant ends with the completion of the Participant Last Visit, which will be performed 10-14 days after the last administration of trial intervention. A post-trial safety follow up is performed 30-40 days after last administration of trial intervention.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Ethinyl Estradiol / Levonorgestrel Oral Tablet	Coated tablet of 20 µg ethinyl estradiol and 100 µg levonorgestrel
DRUG	Aprocitentan	Film-coated tablet of aprocitentan 25 mg

Timeline

• Start date: 2025-01-18
• Primary completion: 2025-02-21
• Completion: 2025-02-21
• First posted: 2025-01-29
• Last updated: 2025-03-11

Locations

1 site across 1 country: Czechia