Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

• ClinicalTrials.gov Identifier: NCT04534699
• Recruitment Status: Completed
• First Posted: September 1, 2020
• Last Update Posted: February 23, 2024
• Sponsor: KBP Biosciences
• Collaborator: Covance
• Information provided by (Responsible Party): KBP Biosciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Moderate Hepatic Impairment; Healthy	Drug: KBP-5074	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 27, 2020
• Actual Primary Completion Date: November 19, 2020
• Actual Study Completion Date: November 19, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hepatic Impaired; KBP-5074 0.5mg tablet orally, Single dose	Drug: KBP-5074; KBP-5074 tablet
Experimental: Matched-control Healthy; KBP-5074 0.5mg tablet orally, Single dose	Drug: KBP-5074; KBP-5074 tablet

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetic Parameter: Maximum observed concentration (Cmax) [ Time Frame: 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
2. Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) [ Time Frame: 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
3. Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) [ Time Frame: 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
4. Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax) [ Time Frame: 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
5. Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States, 32809

United States, Texas

Texas Liver Institute (TLI)

San Antonio, Texas, United States, 78215

Clinical Trials of Texas (CTT)

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

KBP Biosciences

Covance

Investigators

• Study Director: James McCabe; KBP Biosciences

More Information

• Responsible Party: KBP Biosciences
• ClinicalTrials.gov Identifier: NCT04534699
• Other Study ID Numbers: KBP5074-1-006
• First Posted: September 1, 2020
• Last Update Posted: February 23, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KBP Biosciences:

Hepatic Impairment; Moderate Hepatic Impairment; Healthy; KBP-5074

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases