Nuvisan GmbH
Neu-Ulm, Germany
NCT Number: NCT06589726
The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Neu-Ulm, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4.
Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.
Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.
Other names: M5049
Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.
Other names: M5049
Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Time frame: Up to approximately 72 days
Time frame: Up to approximately 72 days
Time frame: Up to approximately 72 days
Time frame: Pre-dose up to 24 hours post-dose
Time frame: Pre-dose up to 24 hours post-dose
Time frame: Pre-dose up to 24 hours post-dose
Time frame: Pre-dose up to 24 hours post-dose
Time frame: Pre-dose up to 24 hours post-dose
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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