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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513393-22-00 | 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 the effect of renal impairment on the pharmacokinetics of enpatoran.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group 1 (Normal Renal Function) | Experimental |
| |
| Group 2 (Impaired Renal Function) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enpatoran | Drug | Participants will receive a single oral dose of enpataron tablets once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Plasma Concentrations of Enpatoran | Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Day 35 | |
| Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG) | Baseline and up to Day 35 |
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Inclusion Criteria:
For Control Group 1 (Normal Renal Function):
For Group 2 (Impaired Renal Function):
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 |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | Schleswig-Holstein | 24105 | 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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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |