Mavorixafor for Healthy Subjects
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mavorixafor and either carbamazepine or efavirenz to assess drug-drug interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carbamazepine
- Efavirenz
- Mavorixafor
Find a Clinic Near You
Who Is Running the Clinical Trial?
X4 Pharmaceuticals
Lead Sponsor