Hepatic Insufficiency
Conditions
Brief 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.
Interventions
DRUGMavorixafor
Mavorixafor will be administered per schedule specified in the arm description.
Sponsors
X4 Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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. 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 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). * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Mavorixafor | 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 | Predose up to 192 hours postdose (Day 1 up to Day 9) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 15 |
| Time to Reach Cmax (Tmax) of Mavorixafor | Predose up to 192 hours postdose (Day 1 up to Day 9) |
Countries
United States
Contacts
STUDY_DIRECTORChief Medical Officer
X4 Pharmaceuticals, Inc.
Outcome results
None listed