Evaluating how mavorixafor interacts with other drugs

A Phase I, Randomized, Open-label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of a Moderate and a Strong CYP3A Inducer on the Pharmacokinetics and Safety of Mavorixafor in Healthy Male and Female Participants

This study is testing how the drug mavorixafor works with other medications, like carbamazepine and efavirenz, in healthy people to see if they affect each other.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: X4 Pharmaceuticals (industry)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06914869 on ClinicalTrials.gov

What this trial studies

This study aims to assess the drug-drug interaction potential of mavorixafor when taken with the CYP3A inducers carbamazepine and efavirenz in healthy participants. It involves administering mavorixafor alongside these medications to observe any interactions that may affect drug metabolism. The study will include both male and female participants who meet specific health criteria, ensuring a controlled environment for accurate results.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 and older with a BMI between 18.5 and 32 kg/m² who do not smoke or use nicotine products.

Not a fit: Patients with a history of using investigational drugs or those with certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safe use of mavorixafor in combination with other medications, enhancing treatment options for patients.

How similar studies have performed: While this study focuses on a specific drug interaction, similar studies have shown success in evaluating drug-drug interactions, indicating a potential for valuable findings.

Eligibility criteria

Key Inclusion Criteria:

* Body mass index (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 electrocardiogram \[ECG\], 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 investigational 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 clinically significant (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 hypersensitivity, or intolerance to study interventions.
* Participant with sodium/leukocyte/thrombocyte 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.

Where this trial is running

Baltimore, Maryland

• Parexel International LLC — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: X4 Pharmaceuticals, Inc.

Conditions: Healthy Participants