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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatic Impaired | Experimental | KBP-5074 0.5mg tablet orally, Single dose |
|
| Matched-control Healthy | Experimental | KBP-5074 0.5mg tablet orally, Single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KBP-5074 | Drug | KBP-5074 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Maximum observed concentration (Cmax) | Maximum observed concentration (Cmax) - Plasma | 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. |
| Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) | Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma | 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. |
| Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) | Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma | 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. |
| Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax) | Time of the maximum observed concentration (tmax) - Plasma | 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. |
| Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations | Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations | Up to 12 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James McCabe | KBP Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center (OCRC) | Orlando | Florida | 32809 | United States | ||
| Texas Liver Institute (TLI) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38329646 | Derived | McCabe J, Zhang J, Yang F, Benn V. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Ocedurenone (KBP-5074) in Individuals with Moderate Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2024 Mar;49(2):229-237. doi: 10.1007/s13318-024-00879-3. Epub 2024 Feb 8. |
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| ID | Term |
|---|---|
| C000716354 | KBP-5074 |
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| San Antonio |
| Texas |
| 78215 |
| United States |
| Clinical Trials of Texas (CTT) | San Antonio | Texas | 78229 | United States |