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A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormonal Contraceptives

NCT06799884 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Drug Drug Interaction

Interventions

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

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-18
Primary Completion
2025-02-21
Completion
2025-02-21

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799884 on ClinicalTrials.gov