Mavorixafor for Healthy Subjects

Overseen By X4 Pharmaceuticals, Inc.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: X4 Pharmaceuticals

Must not be taking: Anticonvulsants, Benzodiazepines, Opiates, others

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 22 days

36 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should not have used any investigational drugs recently and should not use drugs of abuse. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

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.

Research Team

Chief Medical Officer

Principal Investigator

X4 Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for healthy men and women to study how mavorixafor interacts with other drugs. Participants must meet certain health criteria, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

Nonsmokers (no nicotine use for 6 months before Screening and negative cotinine test at Screening and Admission)

Healthy, determined by prestudy medical evaluation at Screening and Admission

My BMI is between 18.5 and 32, and I weigh at least 50 kg.

Exclusion Criteria

Participant has positive coronavirus disease 2019 test on Admission

Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment

Participant has used an investigational drug within 30 days prior to Screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive mavorixafor and either carbamazepine or efavirenz to assess drug-drug interactions

22 days

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Carbamazepine
• Efavirenz
• Mavorixafor

Trial Overview The trial tests the interaction of mavorixafor, a new drug, with carbamazepine and efavirenz, which affect liver enzymes that break down many medicines. It aims to understand how these combinations work in healthy individuals.

Participant Groups

Group I: Cohort 2: Mavorixafor and Efavirenz Experimental Treatment 2 Interventions

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.

Group II: Cohort 1: Mavorixafor and Carbamazepine Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

X4 Pharmaceuticals

Lead Sponsor

Trials

11

Recruited

400+