Clinical trial NCT04534699: Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate Hepatic Impairment
Healthy
Keywords: Hepatic Impairment
Moderate Hepatic Impairment
Healthy
KBP-5074
Lead sponsor: KBP Biosciences
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2020-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
timeFrame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
measure: Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
timeFrame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
measure: Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
timeFrame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
measure: Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax)
timeFrame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
measure: Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations
timeFrame: Up to 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center (OCRC)
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute (TLI)
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas (CTT)
state: Texas
Study officials:
affiliation: KBP Biosciences
name: James McCabe
role: STUDY_DIRECTOR
References: