NCT07214922

Relative Bioavailability of Evobrutinib Tablet Batches

A Phase I, Open-Label Study of the Relative Bioavailability of Evobrutinib Tablet Manufacturing Batches in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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 main purpose of the study is to compare the Pharmacokinetics (PK), safety and tolerability of different manufacturing batches of M2951 tablet formulation relative to a reference batch under fasted conditions in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment A	Participants will receive single dose of Treatment A in treatment period 1, 2, 3 or 4 under fasted conditions.
DRUG	Treatment B	Participants will receive single dose of Treatment B in treatment period 1, 2, 3 or 4 under fasted conditions.
DRUG	Treatment C	Participants will receive single dose of Treatment C in treatment period 1, 2, 3 or 4 under fasted conditions.
DRUG	Treatment D	Participants will receive single dose of Treatment D in treatment period 1, 2, 3 or 4 under fasted conditions.

Timeline

• Start date: 2023-01-18
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2025-10-09
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

1 site across 1 country: Germany