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Completed

NCT Number: NCT06914869

Drug-Drug Interaction Potential of Mavorixafor

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International LLC

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mavorixafor

Drug

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

carbamazepine

Drug

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

Efavirenz

Drug

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

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

Sponsors and collaborators

Lead sponsor

X4 Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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