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Liver Function's impact on drug levels under study

NCT ID NCT06952634

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the body processes a drug called ESK001 in people with different levels of liver function. Researchers gave a single dose to 32 adults, including healthy volunteers and those with mild, moderate, or severe liver impairment. The goal was to measure drug levels in the blood and check for side effects. This helps doctors understand if dose adjustments are needed for patients with liver problems.

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

32 people

The number who actually took part.

Started

Apr 2025

Finished

Mar 2026

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 75 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 for All Participants: * Body mass index between 18.0 and 40.0 kg/m2 Key Inclusion Criteria for Participants with Hepatic Impairment: * Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history Key Exclusion Criteria for All Participants: * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility Key Exclusion Criteria for Healthy Volunteer: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. * Positive hepatitis panel and/or positive human immunodeficiency virus test. Key Exclusion Criteria for Participants with Hepatic Impairment: * History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening. * History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study. * Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee. * QTcF \> 480 ms for males or \> 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Alliance for Multispecialty Research

    Knoxville, Tennessee, 37920, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33104, United States

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