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New drug tested in patients with liver disease: safety first

NCT ID NCT04534699

Knowledge-focused Sponsor: KBP Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study looked at how the drug KBP-5074 behaves in people with moderate liver impairment compared to healthy volunteers. Twelve adults received a single dose, and researchers monitored safety and drug levels in the blood. The goal was to see if liver problems change how the drug is processed, which is important for future dosing recommendations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KBP-5074 (a tablet drug)
What this could lead to
If successful, this study could help doctors understand how to safely dose KBP-5074 in patients with liver problems.
What could go wrong
This is a very early, small study with only 12 people, so results may not apply to everyone. It only looks at safety and drug levels, not whether the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Aug 2020

Finished

Nov 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Moderate hepatic impairment

Contacts and locations

Locations

  • Clinical Trials of Texas (CTT)

    San Antonio, Texas, 78229, United States

  • Orlando Clinical Research Center (OCRC)

    Orlando, Florida, 32809, United States

  • Texas Liver Institute (TLI)

    San Antonio, Texas, 78215, United States

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