The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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.
Nuvisan GmbH
Neu-Ulm, Germany
Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran
Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin
Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 72 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Time frame: Up to approximately 72 days
Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Time frame: Up to approximately 72 days
ECG Parameters: QT Interval, heart rate-corrected QT interval (QTc), individual corrected QT interval (QTcI), PR Interval, QRS interval and RR Interval
Time frame: Pre-dose up to 24 hours post-dose
ECG Parameter: Heart Rate (HR)
Time frame: Pre-dose up to 24 hours post-dose
Number of Participants with T-wave Morphology Changes and U-wave Presence
Time frame: Pre-dose up to 24 hours post-dose
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
Time frame: Pre-dose up to 24 hours post-dose
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Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.
Pharmacokinetic (PK) Plasma Concentrations of Moxifloxacin
Time frame: Pre-dose up to 24 hours post-dose