Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates

Phase 1 Completed 40 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Non-randomizedSequentialOpen-labelTreatment

Summary

This study consisted of 2 parts: Part 1 and 2. The purpose of this study was to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in Part-1 and sumatriptan in Part-2 of the study.

Timeline

Start: 2021-10-04
Primary completion: 2021-12-10
Completion: 2021-12-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Digoxin	Other / unclassified	0.25 mg	Oral
Subject	Evobrutinib	Small molecule	45 mg	Oral
Subject	Metformin	Small molecule	10 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral
Subject	Sumatriptan	Unknown	25 mg	Oral

Indications

No indication recorded.