Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open Label, Nonrandomized, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 in Subjects With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Conditions
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Healthy, Moderate Hepatic Impairment

Intervention / Treatment
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* Drug: KBP-5074


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Males or females, of any race, between 18 and 80 years of age, inclusive, at screening. Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening. Subjects with normal hepatic function must be in good health. Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B. Key Exclusion Criteria: Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study. Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer. Use of mineralocorticoids or MRAs (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor. Subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatic Impaired<br>KBP-5074 0.5mg tablet orally, Single dose | Drug: KBP-5074<br>* KBP-5074 tablet<br>|
| Experimental: Matched-control Healthy<br>KBP-5074 0.5mg tablet orally, Single dose | Drug: KBP-5074<br>* KBP-5074 tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074