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Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

Primary Purpose

Moderate Hepatic Impairment, Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

KBP-5074

About this trial

This is an interventional treatment trial for Moderate Hepatic Impairment focused on measuring Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

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 Exclusion Criteria:

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.

Sites / Locations

Orlando Clinical Research Center (OCRC)
Texas Liver Institute (TLI)
Clinical Trials of Texas (CTT)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hepatic Impaired

Matched-control Healthy

Arm Description

KBP-5074 0.5mg tablet orally, Single dose

Outcomes

Primary Outcome Measures

Pharmacokinetic Parameter: Maximum observed concentration (Cmax)

Maximum observed concentration (Cmax) - Plasma

Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)

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)

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)

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

Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations

Secondary Outcome Measures

Full Information

NCT ID

NCT04534699

First Posted

August 27, 2020

Last Updated

January 7, 2021

Sponsor

KBP Biosciences

Collaborators

Covance

1. Study Identification

Unique Protocol Identification Number

NCT04534699

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 27, 2020 (Actual)

Primary Completion Date

November 19, 2020 (Actual)

Study Completion Date

November 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KBP Biosciences

Collaborators

Covance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate Hepatic Impairment, Healthy

Keywords

Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hepatic Impaired

Arm Type

Experimental

Arm Description

KBP-5074 0.5mg tablet orally, Single dose

Arm Title

Matched-control Healthy

Arm Type

Experimental

Arm Description

KBP-5074 0.5mg tablet orally, Single dose

Intervention Type

Drug

Intervention Name(s)

KBP-5074

Intervention Description

KBP-5074 tablet

Primary Outcome Measure Information:

Title

Pharmacokinetic Parameter: Maximum observed concentration (Cmax)

Description

Maximum observed concentration (Cmax) - Plasma

Time Frame

0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.

Title

Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)

Description

Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma

Time Frame

0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.

Title

Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)

Description

Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma

Time Frame

0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.

Title

Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax)

Description

Time of the maximum observed concentration (tmax) - Plasma

Time Frame

0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.

Title

Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations

Description

Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations

Time Frame

Up to 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James McCabe

Organizational Affiliation

KBP Biosciences

Official's Role

Study Director

Facility Information:

Facility Name

Orlando Clinical Research Center (OCRC)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Texas Liver Institute (TLI)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Clinical Trials of Texas (CTT)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

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