Evobrutinib's Effect on Oral Contraceptive in Healthy Women
This study aims to evaluate how Evobrutinib affects the effectiveness of oral contraceptives in healthy women.
Evobruitnib
+ Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Inclusion Criteria: * 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) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * 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 * Participants with history of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening * Participants with history of shingles within 12 months prior to Screening * Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines \[e.g., Severe acute respiratory syndrome coronavirus 2 (SARSCoV2) vaccines\] is allowed until 4 weeks before admission to CRU, thereafter it is prohibited until the end of the study * Note: In case of clinical symptoms, the participant should be symptom-free for at least 1 week prior to admission to Clinical Research Unit (CRU) * Other protocol defined exclusion criteria could apply
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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