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Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive

NCT07215806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-14

Study results available
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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.

* Study Duration: up to 46 days
* Treatment Duration: Days 4 to 17 (14 days treatment with M2951); Days 1 and 15 (2 days treatment with Combined Oral Contraceptive \[COC\])
* Visit Frequency: Participants were resident in the Clinical Research Unit from Day -1 to Day 18.

Conditions

  • Healthy

Interventions

DRUG

Evobruitnib

Participants received Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.

DRUG

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

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2022-11-25
Completion
2022-11-25

Countries

  • Germany

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 NCT07215806 on ClinicalTrials.gov