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
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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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