ClinicalTrials.gg
CompletedNCT06914869Updated Jul 1, 2025

Drug-Drug Interaction Potential of Mavorixafor

A Phase 1 interventional study of Mavorixafor and Carbamazepine in Healthy Participants, sponsored by X4 Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by X4 Pharmaceuticals · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2025, 1 year 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate drug-drug interaction (DDI) of orally administered mavorixafor with cytochrome P3A (CYP3A) inducers carbamazepine (a strong CYP3A inducer) or efavirenz (a moderate CYP3A inducer) in healthy male and female participants.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

X4 Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • (BMI) between 18.5 and 32 kilograms (kg)/square meter (m\^2), inclusive, and body weight not less than 50 kg at Screening.
  • Nonsmokers (or other tobacco or nicotine-containing products, in any form, including e-cigarettes and vaping) as determined by history (no nicotine use for 6 months before Screening) and by negative cotinine test at Screening and Admission.
  • Healthy, determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead [ECG], and clinical laboratory evaluations) at Screening and Admission. A repeat test (only once per visit) for vitals, ECG, and/or clinical laboratory evaluations may be performed at the investigator's discretion to confirm results.

Key Exclusion Criteria:

  • Participant has used an drug (including mavorixafor) within 30 days (90 days for biologics), or 5 half-lives, whichever is longer prior to Screening.
  • Participant has a history of or currently suffers from an active illness considered to be (CS) by the investigator or any other illness that the investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results.
  • Participant has CS history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, metabolic, allergic, hematological, or psychiatric disorder(s) as determined by the investigator or designee.
  • Female participant is breastfeeding, pregnant, or plans to be pregnant within the duration of the study and up to 4 weeks after completion of the study.
  • Use any drugs of abuse (medical or recreational) for at least 30 days prior to first study intervention administration as documented by a history and positive results for urine drug screening (for example, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids), at Screening and/or Admission.
  • Participant has positive coronavirus disease 2019 test on Admission confirmed by rapid antigen testing.
  • Receipt of any vaccine within 30 days prior to first study intervention or plans to receive any vaccination during the study.
  • Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.

Specific exclusion criteria for Cohort 1:

  • Participant with a history of drug-induced bone marrow depression, hepatic disorders (including porphyrias), severe cutaneous reactions, myotonic dystrophy, psychiatric disorders (including psychosis, depression, and suicidal behavior or ideation), epileptic seizures, increased ocular pressure, or urinary retention syndrome.
  • Participants with the human leukocyte antigens (HLA)-A*31:01 or HLA-B*15:02 allele, known , or intolerance to study interventions.
  • Participant with sodium/leukocyte/ count below the lower limit of normal at Screening and Admission.
  • Participant who previously experienced hypersensitivity reaction to anticonvulsants including phenytoin, primidone, and phenobarbital.

Specific exclusion criteria for Cohort 2:

  • Participants with previously demonstrated CS hypersensitivity (for example, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz.
  • Participants with a history of serious psychiatric events such as severe depression, suicidal ideation, nonfatal suicide attempts, paranoid and manic reactions.

NOTE: Other protocol-defined inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Cohort 1: Mavorixafor and Carbamazepine

    Participants will receive a single dose of mavorixafor administered on Day 1 and a single dose of mavorixafor administered on Day 18 on an empty stomach, after an overnight fast (at least 10 hours). Participants will receive carbamazepine administered orally twice daily (BID) on Days 6 through Day 22, 30 minutes after the end of a meal.

    Drug: Mavorixafor · Drug: Carbamazepine

  • Experimental
    Cohort 2: Mavorixafor and Efavirenz

    Participants will receive a single dose of mavorixafor administered on Day 1 and a single dose of mavorixafor administered on Day 18 on an empty stomach, after an overnight fast (at least 10 hours). Participants will receive efavirenz administered once daily (QD) on Days 6 through 22, at bedtime, at least 4 hours after the end of a meal.

    Drug: Mavorixafor · Drug: Efavirenz

Interventions

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

  • DrugCarbamazepine

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

  • DrugEfavirenz

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

06

What researchers measure

Primary outcomes

  1. Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

  2. Cohort 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

  3. Cohort 2: Cmax of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

  4. Cohort 2: AUC0-last of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

Secondary outcomes

  1. Cohort 1: Time to Reach Cmax (Tmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

  2. Cohort 2: Tmax Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz

    Time frame: Predose up to 120 hours postdose on Days 1 and 18

  3. Cohort 1: Predose Concentration (Ctrough) of Carbamazepine

    Time frame: Predose on Days 14, 16, and 18

  4. Cohort 2: Ctrough of Efavirenz

    Time frame: Predose on Days 14, 16, and 18

  5. Cohorts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 up to Day 33

07

Study locations

1 site
  • Parexel International LLC
    Baltimore, Maryland 21225, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06914869
Lead sponsor
X4 Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 6, 2025
Start date
Feb 18, 2025
Primary completion
May 19, 2025
Completion
May 19, 2025
Last update
Jul 1, 2025

Study contacts

Chief Medical Officer
study director · X4 Pharmaceuticals, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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