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Relative Bioavailability of Evobrutinib Tablet Batches

NCT07214922 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-23

Study results available
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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

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2023-02-24
Completion
2023-02-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214922 on ClinicalTrials.gov