NCT06589726

A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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 enpatoran on cardiac repolarization (i.e. prolongation of QT interval).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4.
DRUG	Moxifloxacin	Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.
DRUG	Enpatoran low dose	Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.
DRUG	Enpatoran high dose	Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.

Timeline

• Start date: 2024-09-10
• Primary completion: 2024-12-02
• Completion: 2024-12-02
• First posted: 2024-09-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: Germany