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

NCT06589726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • 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
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2024-12-02
Completion
2024-12-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT06589726 on ClinicalTrials.gov