Status:
COMPLETED
Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
FEMALE
18-68 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive \[Ethinyl estradiol/Norethisterone (EE/NET)\] in healthy female participants. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07215806
Start Date
August 24 2022
End Date
November 25 2022
Last Update
November 14 2025
Active Locations (1)
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1
Nuvisan GmbH
Neu-Ulm, Germany