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

Conditions

• Hepatic Insufficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Mavorixafor — DRUG
  Mavorixafor will be administered per schedule specified in the arm description.

Study Details

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.

Key Dates

Start date

Feb 28, 2025

Status verified

Apr 2025

Primary completion

Mar 31, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Child-Pugh A
  Participants with mild HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.
• Experimental: Group 2: Child-Pugh B
  Participants with moderate HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.
• Experimental: Group 3: Child-Pugh C
  Participants with severe HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period.
• Experimental: Group 4: HVs
  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.
• Experimental: Group 5: HVs
  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.
• Experimental: Group 6: HVs
  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.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Mavorixafor [ Time Frame: Predose up to 192 hours postdose (Day 1 up to Day 9) ]

Central Contacts

• X4 Pharmaceuticals, Inc.
  857-529-5779
  [email protected]

Locations (4)

Find similar trials in Montclair, CA

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