NCT07215806

Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-11-25
• Completion: 2022-11-25
• First posted: 2025-10-14
• Last updated: 2025-11-14
• Results posted: 2025-11-14

Locations

1 site across 1 country: Germany