Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534699
• Other study ID #: KBP5074-1-006
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2020
• Est. completion date: November 19, 2020

Study information

• Verified date: February 2024
• Source: KBP Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Liver Diseases
• Moderate Hepatic Impairment

Intervention

Drug:
• KBP-5074
KBP-5074 tablet

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
KBP Biosciences	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-8)	Area under the concentration-time curve from time 0 to infinity (AUC0-8) - Plasma	0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Primary	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.
Primary	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.
Primary	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