NCT04697511

Drug-drug Interaction Study of Evobrutinib With Midazolam in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (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 study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Midazolam	Participants will receive single oral dose of midazolam on Days 1, 3 and 13 under fed conditions.
DRUG	M2951	Participants will receive multiple oral doses (twice daily) of M2951 on Day 3 to Day 13 under fed conditions.

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-02-25
• Completion: 2021-02-25
• First posted: 2021-01-06
• Last updated: 2021-03-23

Locations

1 site across 1 country: Germany