NCT07214935

A TQT Study of Effect of M2951 on Cardiac Repolarization

A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Evobrutinib on the QTc (Corrected QT) Interval in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo matched to M2951	Participants will receive single oral dose of placebo matched to M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
DRUG	Moxifloxacin	Participants will receive single oral dose of moxifloxacin in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
DRUG	M2951 Low Dose	Participants will receive single oral low dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
DRUG	M2951 High Dose	Participants will receive single oral high dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2025-10-09
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

1 site across 1 country: Germany