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NCT06858696
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
Phase 1 trial testing Mavorixafor in Hepatic Insufficiency in 48 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | X4 Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 28 February 2025 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 April 2026 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Mavorixafor (MAVORIXAFOR) — full drug profile →
Conditions studied
- Hepatic Insufficiency — all drugs for Hepatic Insufficiency →
Sponsor
X4 Pharmaceuticals — full company profile →
Who can join
Adults 18 to 75, any sex, with Hepatic Insufficiency. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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)
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06858696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mavorixafor
Trials testing the same drug.
- NCT06914869 — Drug-Drug Interaction Potential of Mavorixafor · Phase 1 · completed
- NCT04154488 — A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders · Phase 1, PHASE2 · completed
- NCT04274738 — A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tum · Phase 1 · completed
Other recruiting trials for Hepatic Insufficiency
Currently open trials in the same condition.
- NCT06957756 — A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
Other X4 Pharmaceuticals trials
Trials by the same sponsor.
- NCT06914869 — Drug-Drug Interaction Potential of Mavorixafor · Phase 1 · completed
- NCT04154488 — A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders · Phase 1, PHASE2 · completed
- NCT04274738 — A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tum · Phase 1 · completed
- NCT02923531 — Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma · Phase 1, PHASE2 · terminated
- NCT02823405 — X4P-001 and Pembrolizumab in Patients With Advanced Melanoma · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06858696 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by X4 Pharmaceuticals
- Last refreshed: 2 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06858696.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing