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An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment | Experimental |
| |
| Normal Healthy Matches | Experimental |
| |
| Mild Hepatic Impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-7117 | Drug | Single Dose of MT-7117 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of MT-7117 | 0-96 Hours | |
| Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117 | 0-96 Hours | |
| Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117 | 0-96 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum plasma concentration (tmax) of MT-7117 | 0-96 Hours | |
| Plasma terminal elimination half-life (t1/2) of MT-7117 | 0-96 Hours | |
| Apparent oral clearance (CL/F) of MT-7117 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Clinical Pharmacology Unit | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38746989 | Derived | Ogasawara A, Ide R, Inoue S, Teng R, Kawaguchi A. Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clin Pharmacol Drug Dev. 2024 Jul;13(7):729-738. doi: 10.1002/cpdd.1413. Epub 2024 May 15. |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 0-96 Hours |
| Apparent volume of distribution (Vz/F) of MT-7117 | 0-96 Hours |
| fraction of unbound drug in plasma or serum (fu) of MT-7117 | 0-96 Hours |
| Number of participants with Adverse events (AEs) and Serious Adverse Events (SAEs) | 0-96 Hours |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |