Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
- Registration Number
- NCT04534699
- Lead Sponsor
- KBP Biosciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hepatic Impaired KBP-5074 KBP-5074 0.5mg tablet orally, Single dose Matched-control Healthy KBP-5074 KBP-5074 0.5mg tablet orally, Single dose
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameter: Maximum observed concentration (Cmax) 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. Maximum observed concentration (Cmax) - Plasma
Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations Up to 12 days Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax) 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose. Time of the maximum observed concentration (tmax) - Plasma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Orlando Clinical Research Center (OCRC)
🇺🇸Orlando, Florida, United States
Clinical Trials of Texas (CTT)
🇺🇸San Antonio, Texas, United States
Texas Liver Institute (TLI)
🇺🇸San Antonio, Texas, United States