Liver function may change how mavorixafor works in the body
NCT ID NCT06858696
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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39 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Jan 2026
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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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
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Catalina Research Institute, LLC
Montclair, California, 91763, United States
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Catalina Research Institute, LLC
Rialto, California, 91763, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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Texas Liver Institute/Alamo Medical Research
San Antonio, Texas, 78215, United States
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