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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a new drug, mavorixafor, interacts with other medicines in healthy individuals. Researchers seek to observe the effects when mavorixafor is taken with either carbamazepine or efavirenz, both of which influence how other drugs function in the body. The study seeks healthy individuals who do not smoke or use nicotine and have not recently taken any investigational drugs. Those who are generally healthy and meet these criteria might find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mavorixafor has been tested in 99 cancer patients, either alone or with other drugs, at doses ranging from 200 to 600 mg daily. The treatment was generally well-tolerated. However, carbamazepine may cause mavorixafor to break down faster in the body, potentially affecting its effectiveness, though specific safety data for this combination is lacking.

For efavirenz, studies indicate that it can slow down the breakdown of mavorixafor. While efavirenz sometimes causes side effects when combined with other drugs, there is no specific data about increased risks when used with mavorixafor.

In both combinations, mavorixafor has generally been safe on its own, but interactions with these other drugs are still under study. Participants considering joining the trial should know that mavorixafor is already FDA approved for another condition, suggesting it is generally safe. It is important to discuss personal health risks with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about mavorixafor because it offers a novel approach to treatment by enhancing the body's response to certain medications. Unlike many standard treatments, which often focus on directly attacking symptoms or the disease, mavorixafor works by modulating the immune system to improve how the body processes other drugs. This can be particularly beneficial when used in combination with medications like carbamazepine and efavirenz, potentially increasing their effectiveness or reducing side effects. By targeting and optimizing the body's response pathways, mavorixafor opens new possibilities for improving treatment outcomes in a range of conditions.

What evidence suggests that this trial's treatments could be effective?

This trial investigates how mavorixafor interacts with other drugs, particularly those affecting a liver enzyme called CYP3A, which helps the body process certain medications. Participants will be divided into two cohorts: one will receive mavorixafor with carbamazepine, and the other with efavirenz. Both carbamazepine and efavirenz can alter CYP3A function. Understanding these interactions is crucial, as they could influence mavorixafor's effectiveness in the body. Although specific data on its efficacy in treating conditions is not yet available, the research aims to ensure mavorixafor's safety and effectiveness when used with these drugs. ^{6 7 8 9 10}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

X4 Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06914869?term=X4%20pharmaceuticals&intr=mavorixafor&rank=1

Study Details | Drug-Drug Interaction Potential of Mavorixafor

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-9b7be

Mavorixafor for Healthy Subjects · Info for Participants

The main purpose of this study is to evaluate drug-drug interaction (DDI) of orally administered mavorixafor with cytochrome P3A (CYP3A) inducers ...

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/XFOR/pressreleases/33223069/x4-pharmaceuticals-completes-key-study-on-mavorixafors-drug-interaction-potential/

X4 Pharmaceuticals Completes Key Study on Mavorixafor's ...

The study aimed to evaluate the drug-drug interaction potential of mavorixafor when combined with CYP3A inducers, carbamazepine and efavirenz, ...

4.

tipranks.com

tipranks.com/news/company-announcements/x4-pharmaceuticals-completes-key-study-on-mavorixafors-drug-interaction-potential

X4 Pharmaceuticals Completes Key Study on Mavorixafor's ...

The study aimed to assess how mavorixafor interacts with cytochrome P3A (CYP3A) inducers, specifically carbamazepine and efavirenz, in healthy participants.

5.

trialstoday.org

trialstoday.org/list/print/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) ...

6.

go.drugbank.com

go.drugbank.com/drugs/DB05501

Mavorixafor: Uses, Interactions, Mechanism of Action

Carbamazepine, The metabolism of Mavorixafor can be increased when combined with Carbamazepine. Carbinoxamine, The risk or severity of QTc prolongation can be ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/mavorixafor-oral-route/description/drg-20568652

Mavorixafor (oral route) - Side effects & dosage

Mavorixafor is used to increase the number of white blood cells (eg, neutrophils, lymphocytes) in patients with an immune system problem called WHIM syndrome.

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/27/NCT03005327/Prot_000.pdf

This study will be conducted according to the protocol and ...

As of 14 May 2020, a total of 99 oncology patients have been dosed with mavorixafor at doses ranging from 200 to 600 mg QD as monotherapy or in combination with ...

9.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/XFOR/pressreleases/33178587/x4-pharmaceuticals-completes-key-study-on-mavorixafors-drug-interaction-potential/

X4 Pharmaceuticals Completes Key Study on Mavorixafor's ...

This research is significant as it provides insights into the safety and efficacy of mavorixafor when used alongside other medications.

10.

healio.com

healio.com/clinical-guidance/drugs/carbamazepine

carBAMazepine: Uses, Side Effects & Dosage

Find clinical guidance on carBAMazepine, including indications, dosing, safety, side effects and evidence-based insights for healthcare professionals.