Mavorixafor for Liver Failure

Recruiting at 3 trial locations

Overseen By X4 Pharmaceuticals, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: X4 Pharmaceuticals

Must not be taking: Investigational drugs

Disqualifiers: Pregnancy, Active malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants with liver issues be on a stable medication regimen, meaning you should not start new medications or change doses within 28 days before taking mavorixafor. If you're already on stable medications, you likely won't need to stop them.

Research Team

Chief Medical Officer

Principal Investigator

X4 Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for adults with liver impairment and healthy volunteers matched by age, weight, and gender. Participants must not have other significant medical conditions or be taking conflicting medications that could affect the study results.

Inclusion Criteria

I smoke less than 10 cigarettes a day or use an equivalent amount of nicotine and can stop during the study.

I have a long-term liver condition with a specific diagnosis related to liver tissue damage.

I weigh over 50 kg and my BMI is between 18.0 and 40.0.

Exclusion Criteria

Positive hepatitis C antibody test result at screening

Has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of mavorixafor

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of mavorixafor orally on an empty stomach after a minimum 10-hour fasting period

Single dose

Follow-up

Participants are monitored for safety and effectiveness after receiving the single dose

4 weeks

Treatment Details

Interventions

• Mavorixafor

Trial Overview The study measures how a single dose of Mavorixafor is processed in the body (pharmacokinetics) and its safety in people with different levels of liver function compared to those with normal liver health.

Participant Groups

Group I: Group 6: HVs Experimental Treatment 1 Intervention

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.

Group II: Group 5: HVs Experimental Treatment 1 Intervention

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.

Group III: Group 4: HVs Experimental Treatment 1 Intervention

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.

Group IV: Group 3: Child-Pugh C Experimental Treatment 1 Intervention

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

Group V: Group 2: Child-Pugh B Experimental Treatment 1 Intervention

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

Group VI: Group 1: Child-Pugh A Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

X4 Pharmaceuticals

Lead Sponsor

Trials

11

Recruited

400+