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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512841-17-00 | Other Identifier | EU CT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: A-B-C-D | Experimental | 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. |
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| Treatment Sequence 2: B-D-A-C | Experimental | 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. |
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| Treatment Sequence 3: C-A-D-B | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | Germany |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
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| Treatment Sequence 4: D-C-B-A | Experimental | 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. |
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| Moxifloxacin | Drug | Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4. |
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| Enpatoran low dose | Drug | Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4. |
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| Enpatoran high dose | Drug | Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4. |
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| 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 |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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