ClinicalTrials.gg
CompletedNCT06858696Updated Jul 15, 2026

A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function

A Phase 1 interventional study of Mavorixafor in Hepatic Insufficiency, sponsored by X4 Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by X4 Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to measure the effect of HI on the PK, safety, and tolerability of a single dose of mavorixafor compared to matched healthy volunteers (HVs) with normal hepatic function.

02

Conditions studied

  • Hepatic Insufficiency

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03

In context

Hepatic Insufficiency

113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.

This study's enrollment of 39 is above the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

X4 Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Body weight is more than 50.0 kilograms (kg) with (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 findings from medical history, physical examination, 12-lead (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 or drugs in a similar pharmacological class with mavorixafor.
  • Has an active or history (≤ 5 years prior to enrollment) of solid, , or hematologic malignancy.
  • A known history of positive serology or viral load for (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 surface antigen (HbsAg) or hepatitis B core antibody (HbcAb).
  • Positive antibody test result at screening.
  • Have received mavorixafor previously.
  • Has used an 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, 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 \< 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.

Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Group 1: Child-Pugh A

    Participants with mild HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

  • Experimental
    Group 2: Child-Pugh B

    Participants with moderate HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

  • Experimental
    Group 3: Child-Pugh C

    Participants with severe HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

  • Experimental
    Group 4: HVs

    HVs matched with the mild HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

  • Experimental
    Group 5: HVs

    HVs matched with the moderate HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

  • Experimental
    Group 6: HVs

    HVs matched with the severe HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.

    Drug: Mavorixafor

Interventions

  • Mavorixafor will be administered per schedule specified in the arm description.

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Mavorixafor

    Time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)

  2. Area Under the Serum Concentration Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mavorixafor

    Time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 up to Day 15

  2. Time to Reach Cmax (Tmax) of Mavorixafor

    Time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)

07

Study locations

4 sites
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Jan 2026, 10 months.

Of 38 industry-sponsored phase 1 interventional studies under Hepatic Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 10 months is above that.

Counting every sponsor, half of 41 studies reached it within 8 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2025
First posted
Mar 5, 2025
StartActual
Feb 28, 2025
Primary completionActual
Jan 12, 2026
CompletionActual
Jan 12, 2026
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06858696
Lead sponsor
X4 Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Feb 28, 2025
Primary completion
Jan 12, 2026
Completion
Jan 12, 2026
Last update
Jul 15, 2026

Study contacts

Chief Medical Officer
study director · X4 Pharmaceuticals, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Mavorixafor

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