CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Evobrutinib +1 moredrug
Likely dose
Evobrutinib 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/NCT05248945
NCT05248945Phase 1Completed
CompareCT.gov

Phase I, Open-Label, Single-Sequence Study of the Effect of Multiple Doses of Carbamazepine on Single-Dose Evobrutinib Pharmacokinetics in Healthy Participants

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Feb 21, 2022·Updated Jan 15, 2026

In Brief

A Phase 1 clinical trial evaluating Evobrutinib and Carbamazepine for Healthy. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of this study was to investigate the effect of multiple doses of carbamazepine on two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details included: Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants were residents in the Clinical Research Unit from Day 1 to Day 20 and returned on Day 26 for a Safety Follow-Up visit.

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedFeb 21, 2022
Enrollment StartJan 13, 2022
Primary CompletionJul 18, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.4 years ago

Interventions

Evobrutinibdrug

Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19

Carbamazepinedrug

Participants received Carbamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily.