Hepatic InsufficiencyPhase 1NCT06858696
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 study testing Mavorixafor in people with Hepatic Insufficiency, run by X4 Pharmaceuticals at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Mavorixafor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Feb 2025to 12 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Catalina Research Institute, LLC
Montclair, California, 91763
Orlando Clinical Research Center
Orlando, Florida, 32809
Catalina Research Institute, LLC
Rialto, California, 91763
Texas Liver Institute/Alamo Medical Research
San Antonio, Texas, 78215
About this study
Official title: An Open-label, Non-randomized Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
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.
- Conditions
- Hepatic Insufficiency
- Being tested
- Mavorixafor
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavorixaforDrug
Mavorixafor will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Child-Pugh A | Experimental | Participants with mild HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. Receives: Drug: Mavorixafor |
| Group 2: Child-Pugh B | Experimental | Participants with moderate HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. Receives: Drug: Mavorixafor |
| Group 3: Child-Pugh C | Experimental | Participants with severe HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. Receives: Drug: Mavorixafor |
| Group 4: HVs | Experimental | 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. Receives: Drug: Mavorixafor |
| Group 5: HVs | Experimental | 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. Receives: Drug: Mavorixafor |
| Group 6: HVs | Experimental | 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. Receives: Drug: Mavorixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor
Measured: Predose up to 192 hours postdose (Day 1 up to Day 9)
Area Under the Serum Concentration Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mavorixafor
Measured: Predose up to 192 hours postdose (Day 1 up to Day 9)
Secondary outcomes (2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Day 15
Time to Reach Cmax (Tmax) of Mavorixafor
Measured: Predose up to 192 hours postdose (Day 1 up to Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start28 Feb 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- X4 Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, X4 Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858696
- Sponsor's protocol ID
- X4P-001-003
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06858696
- Acronym / sponsor ID
- X4P-001-003
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- X4 PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Child-Pugh A | Experimental | Drug: MavorixaforParticipants with mild HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
| Group 2: Child-Pugh B | Experimental | Drug: MavorixaforParticipants with moderate HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
| Group 3: Child-Pugh C | Experimental | Drug: MavorixaforParticipants with severe HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
| Group 4: HVs | Experimental | Drug: MavorixaforHVs 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. |
| Group 5: HVs | Experimental | Drug: MavorixaforHVs 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. |
| Group 6: HVs | Experimental | Drug: MavorixaforHVs 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MavorixaforMavorixafor will be administered per schedule specified in the arm description. | Drug | Group 1: Child-Pugh A, Group 2: Child-Pugh B, Group 3: Child-Pugh C, Group 4: HVs, Group 5: HVs, Group 6: HVs |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor
Time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)
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)
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 15
Time to Reach Cmax (Tmax) of Mavorixafor
Time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
X4 Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mavorixafor in people with Hepatic Insufficiency, run by X4 Pharmaceuticals at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor (time frame: Predose up to 192 hours postdose (Day 1 up to Day 9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.