Healthy, Moderate Hepatic Impairment
Conditions
Keywords
Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074
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.
Interventions
DRUGKBP-5074
KBP-5074 tablet
Sponsors
Covance
KBP Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Males or females, of any race, between 18 and 80 years of age, inclusive, at screening. 2. Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening. 3. Subjects with normal hepatic function must be in good health. 4. Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B. Key
Exclusion criteria
1. Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study. 2. Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2. 3. 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. 4. 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. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed