CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Evobruitnib +1 moredrug
Likely dose
Evobruitnib 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07215806
NCT07215806Phase 1Completed
CompareCT.gov

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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Oct 14, 2025·Updated Nov 14, 2025

In Brief

A Phase 1 clinical trial evaluating Evobruitnib and Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)] for Healthy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedOct 14, 2025
Enrollment StartAug 24, 2022
Primary CompletionNov 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9 months ago

Interventions

Evobruitnibdrug

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

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

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.