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Completed

NCT Number: NCT04534699

Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

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.

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Key information

Conditions

Moderate Hepatic Impairment Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center (OCRC), Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KBP-5074

Drug

KBP-5074 tablet

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

KBP Biosciences

Industry

Collaborators

  • Covance

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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