Mavorixafor for Liver Failure

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: X4 Pharmaceuticals

No Placebo Group

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.

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.

I am in good health with no significant medical issues.

Exclusion Criteria

I have had a liver transplant or am among the top 5% awaiting one.

I have taken mavorixafor before.

I am not pregnant or breastfeeding.

I am allergic to mavorixafor or similar drugs.

I have or had cancer in the past 5 years.

I have tested positive for HIV or have AIDS.

I currently have COVID-19 or tested positive recently.

I have tested positive for hepatitis B.

My kidney function is reduced, and I have abnormal blood salt levels.

I have a history of liver disease.

Participant Groups

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.

6Treatment groups

Experimental Treatment

Group I: Group 6: HVsExperimental Treatment1 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: HVsExperimental Treatment1 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: HVsExperimental Treatment1 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 CExperimental Treatment1 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 BExperimental Treatment1 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 AExperimental Treatment1 Intervention

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