Liver function may change how mavorixafor works in the body

NCT ID NCT06858696

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study investigates how a single dose of mavorixafor is processed in people with mild to moderate liver impairment compared to healthy volunteers with normal liver function. Researchers will measure drug levels in the blood and monitor safety and tolerability. The goal is to understand whether liver problems affect how the body handles mavorixafor, which could guide 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
mavorixafor
What this could lead to
If successful, this study could help determine safe and effective dosing of mavorixafor for people with liver impairment.
What could go wrong
This is an early-phase study with only 39 participants, so results may not apply to everyone. Liver impairment can unpredictably alter drug processing, and safety findings are preliminary.

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

39 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 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: * Body weight is more than 50.0 kilograms (kg) with body mass index (BMI) between 18.0 and 40.0 kg/square meter (m\^2) at the Screening Visit and at Day -1 Visit. * In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations. * Current non-smoker or light smoker, that is, no more than 10 cigarettes or 10 milligrams (mg) equivalent use of nicotine per day by e-vapor cigarette, pipe, cigar, chewing tobacco, nicotine patch, nicotine gum, and able and willing to refrain from smoking and tobacco use during the study. Inclusion criteria applicable to participants with HI Only: * Aside from hepatic insufficiency, the participant is deemed by the Investigator to be sufficiently healthy for study participation, based upon medical history, physical examination, vital signs, and screening laboratory evaluations. * Documented chronic stable liver disease according to CP classification with diagnosis of HI due to parenchymal liver disease. * Currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 28 days of the mavorixafor administration (Day 1). Key Exclusion Criteria: * Female participants/volunteers who are breastfeeding or female participants/ volunteers with a positive pregnancy test at the Screening Visit or at Day -1. * History of allergy to mavorixafor excipients or drugs in a similar pharmacological class with mavorixafor. * Has an active malignancy or history (≤ 5 years prior to enrollment) of solid, metastatic, or hematologic malignancy. * A known history of positive serology or viral load for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome. * Known active COVID-19 infection or a positive test within the local accepted clinical and governmental guidelines for a communicable window. * Positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb). * Positive hepatitis C antibody test result at screening. * Have received mavorixafor previously. * Has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of mavorixafor. Additional exclusion criteria applicable to Volunteers with Normal Hepatic Function Only: * History or evidence of liver disease such as alcoholic liver disease, autoimmune hepatitis, hepatitis B, hepatitis C, primary biliary cirrhosis, primary sclerotic cholangitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug induced liver injury, and/or hepatocellular carcinoma. * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder. * Clinical laboratory test results must be strictly within the normal laboratory reference ranges for liver function and hematology, and for other parameters, deemed as not clinically significant by the Investigator. Additional exclusion criteria applicable to participants with HI Only: * Clinically significant abnormal laboratory values at screening or Day -1, in the judgment of the Investigator. * History of liver transplant or currently in the top 5% of recipients on the transplant list. * Evidence of hepatorenal syndrome or abnormal serum creatinine levels (above upper limit for the local lab) and estimated glomerular filtration rate \< 60 milliliters (mL)/minute (min) or abnormal sodium and potassium levels. * New medication or a change in dose for hepatic encephalopathy within the 3 months prior to admission to the clinical site, unless approved by the Investigator and the study Medical Monitor. * Concurrent conditions that could interfere with safety and/or tolerability measurements. NOTE: Other protocol-defined inclusion and exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hepatic insufficiency are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver failure

As listed by the trial registrant

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

Contacts and locations

Locations

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Catalina Research Institute, LLC

    Rialto, California, 91763, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • Texas Liver Institute/Alamo Medical Research

    San Antonio, Texas, 78215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.