Actively Recruiting
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
Led by X4 Pharmaceuticals · Updated on 2025-04-03
48
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight is more than 50.0 kilograms with BMI between 18.0 and 40.0 kg/m2 at screening and Day -1 visits
- In good health with no clinically significant findings on medical history, physical exam, ECG, vital signs, and lab tests
- Current non-smoker or light smoker (no more than 10 cigarettes or equivalent nicotine use per day) and willing to refrain from tobacco use during the study
- For hepatic impairment group: deemed sufficiently healthy aside from liver disease
- Documented chronic stable liver disease with hepatic impairment due to parenchymal liver disease
- On stable medication regimen without new drugs or dose changes within 28 days before mavorixafor administration
You will not qualify if you...
- Female participants who are breastfeeding or have a positive pregnancy test at screening or Day -1
- Allergy to mavorixafor or similar drugs
- Active malignancy or history of cancer within 5 years prior to enrollment
- Known HIV infection or AIDS
- Active COVID-19 infection or recent positive test
- Positive hepatitis B surface antigen or core antibody
- Positive hepatitis C antibody at screening
- Previous use of mavorixafor
- Use of investigational drugs within 30 days or 5 half-lives before first mavorixafor dose
- For healthy volunteers: history or evidence of liver disease or significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorders
- Lab test results outside normal ranges or clinically significant abnormalities
- For hepatic impairment group: clinically significant abnormal labs at screening or Day -1
- History of liver transplant or top 5% on transplant list
- Evidence of hepatorenal syndrome, abnormal kidney function, or electrolyte imbalances
- Recent medication changes for hepatic encephalopathy within 3 months unless approved
- Concurrent conditions interfering with safety or tolerability assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Not Yet Recruiting
2
Catalina Research Institute, LLC
Rialto, California, United States, 91763
Actively Recruiting
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Not Yet Recruiting
4
Texas Liver Institute/Alamo Medical Research
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
X
X4 Pharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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