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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorX4 Pharmaceuticals

About 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 accepts healthy volunteers

Qualifiers

Body weight is more than 50.0 kilograms (kg) with body mass index (BMI) between 18.0 and 40.0 kg/square meter (m²) 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.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mavorixafor

    Drug

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

Treatment groups

48 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1: Child-Pugh AExperimental treatment 1 intervention
Group B: Group 2: Child-Pugh BExperimental treatment 1 intervention
Group C: Group 3: Child-Pugh CExperimental treatment 1 intervention
Group D: Group 4: HVsExperimental treatment 1 intervention
Group E: Group 5: HVsExperimental treatment 1 intervention
Group F: Group 6: HVsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Observed Plasma Concentration (Cmax) of Mavorixafor

Time frame
Predose up to 192 hours postdose (Day 1 up to Day 9)
2

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)

Secondary outcomes

1

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame
Day 1 up to Day 15
2

Time to Reach Cmax (Tmax) of Mavorixafor

Time frame
Predose up to 192 hours postdose (Day 1 up to Day 9)

Other outcomes

Sponsors and contacts

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