Completed

Evobrutinib's Effect on Oral Contraceptive in Healthy Women

Study Aim

This study aims to evaluate how Evobrutinib affects the effectiveness of oral contraceptives in healthy women.

What is being tested

Evobruitnib

+ Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]

Drug

Who is being recruted

From 18 to 68 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 1

Interventional

Study Start: August 2022

See protocol details

Summary

Principal SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 24, 2022

Actual date on which the first participant was enrolled.

This clinical trial aims to study how a medication called Evobrutinib (also known as M2951) affects the way a commonly used oral contraceptive, which contains Ethinyl estradiol and Norethisterone, is processed in the body. The study involves healthy female participants who are not currently using any hormonal contraceptives. Understanding this interaction is important because it can help ensure that women using both Evobrutinib and this contraceptive have effective and safe contraception. Participants in the study will be staying at a Clinical Research Unit for up to 18 days. During this time, they will take Evobrutinib pills for 14 days and the oral contraceptive on two separate days. Researchers will monitor how the contraceptive is absorbed and processed in the body when taken with Evobrutinib. This is done through regular blood tests and medical check-ups to gather data. The study is designed to ensure participant safety and aims to provide valuable information about potential interactions between these medications.

Official TitleA Phase I, Open-Label, Multiple-Dose Study of the Effect of Evobrutinib on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Participants

NCT07215806

Principal SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 68 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion

Participants have a body weight within 50.0 and 100.0 kilograms (kg) (inclusive) and body mass index within the range 19.0 and 30.0 kilograms per square meter (kg/m^2) (inclusive)

Participants are nonsmokers for at least 6 months preceding Screening

Female participants who are not a Woman of Childbearing Potential (WOCBP)

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9 exclusion criteria prevent from participating

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation

Participants with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study

Participants with prior history of splenectomy or any clinically relevant surgery within 3 months prior to Screening

Participants with history of any malignancy

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants received combined oral contraceptive (COC) \[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\], 0.5 mg of Norethisterone (NET)\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Nuvisan GmbH

Neu-Ulm, GermanyOpen Nuvisan GmbH in Google Maps

CompletedOne Study Center