NCT05248945

DDI Study of Evobrutinib and Carbamazepine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Evobrutinib	Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19
DRUG	Carbamazepine	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.

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2022-02-21
• Last updated: 2026-01-15
• Results posted: 2026-01-15

Locations

1 site across 1 country: Germany