A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06589726
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence 1: A-B-C-D Placebo Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 1: A-B-C-D Moxifloxacin Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 1: A-B-C-D Enpatoran low dose Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 1: A-B-C-D Enpatoran high dose Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 2: B-D-A-C Placebo Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 2: B-D-A-C Moxifloxacin Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 2: B-D-A-C Enpatoran low dose Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 2: B-D-A-C Enpatoran high dose Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 3: C-A-D-B Placebo Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 3: C-A-D-B Enpatoran low dose Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 3: C-A-D-B Enpatoran high dose Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 4: D-C-B-A Placebo Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 4: D-C-B-A Enpatoran low dose Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 4: D-C-B-A Enpatoran high dose Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 3: C-A-D-B Moxifloxacin Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period. Treatment Sequence 4: D-C-B-A Moxifloxacin Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.
- Primary Outcome Measures
Name Time Method Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran Pre-dose on Day 1 (baseline) up to 24 hours post-dose
- Secondary Outcome Measures
Name Time Method Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin Pre-dose on Day 1 (baseline) up to 24 hours post-dose Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Up to approximately 72 days Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity Up to approximately 72 days Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings 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 Pre-dose up to 24 hours post-dose ECG Parameter: Heart Rate (HR) Pre-dose up to 24 hours post-dose Number of Participants with T-wave Morphology Changes and U-wave Presence Pre-dose up to 24 hours post-dose Pharmacokinetic (PK) Plasma Concentrations of Enpatoran Pre-dose up to 24 hours post-dose Pharmacokinetic (PK) Plasma Concentrations of Moxifloxacin Pre-dose up to 24 hours post-dose
Trial Locations
- Locations (1)
Nuvisan GmbH
🇩🇪Neu-Ulm, Germany