NX-5948 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called NX-5948, an experimental therapy. Researchers aim to observe its behavior in the body, particularly when combined with food or other medications. The goal is to understand its safety and how the body processes it. The trial seeks healthy, non-smoking men without significant medical issues. Participants must follow guidelines and avoid certain medications before and during the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements 14 days before the first dose. Additionally, you must avoid certain drugs that affect specific enzymes 28 days before the first dose and acid-reducing agents 7 days before the first dose.
Is there any evidence suggesting that NX-5948 is likely to be safe for humans?
Research has shown that NX-5948 was safe in earlier studies. Although detailed safety data from those studies is not available, press releases indicate that individuals with certain conditions tolerated the treatment well. This suggests that NX-5948 appears safe for humans so far, but further research is necessary to confirm this. As this is an early-phase study, the primary focus is on how the treatment affects healthy individuals and its safety for them.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for fungal infections, which typically involves medications like fluconazole that target fungal cell membranes, NX-5948 presents a novel approach by potentially offering a new mechanism of action. Researchers are excited about NX-5948 because it is being explored for its ability to work effectively under different conditions, whether fasted or fed, and in combination with existing treatments like fluconazole. This versatility in administration could lead to more flexible treatment options for patients, increasing adherence and potentially improving outcomes.
What evidence suggests that NX-5948 could be effective?
Research has shown that NX-5948 could be a promising treatment for certain B-cell cancers. This trial will examine NX-5948 in healthy subjects to understand its pharmacokinetics and safety profile. NX-5948 is a pill that targets and breaks down a protein called BTK, which aids in the growth of these cancer cells. Early studies demonstrated that NX-5948 effectively targets BTK, leading to positive patient outcomes. It is also designed to work in the brain, potentially aiding in the treatment of cancers affecting the central nervous system. Overall, NX-5948 holds potential as a strong treatment option for B-cell cancers.26789
Who Is on the Research Team?
Sarah Injac, MD PhD
Principal Investigator
Nurix Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adults. Specific details about who can join are not provided, but typically participants should have no significant health issues and be willing to follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Food-Effect and Drug-Drug Interaction Study
Participants receive NX-5948 or placebo under fed and fasted conditions, and with fluconazole to evaluate food and drug-drug interactions.
Part 2: Pharmacokinetics Evaluation
Participants receive NX-5948 or placebo to assess pharmacokinetics following 2 doses given 12 hours apart.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NX-5948
Trial Overview
The study tests NX-5948's effects with food and other drugs in the body (pharmacokinetics). It has two parts: one where subjects take NX-5948 or placebo randomly with different meal conditions, and another that measures how the drug moves through and leaves the body.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Experimental: Part 2: NX-5948 PK NX-5948 or placebo administered 2 doses given 12 hours apart under fasted conditions
Period 1: NX-5948 or placebo administered under fed conditions Period 2: NX-5948 or placebo administered under fasted conditions Period 3: Fluconazole and single dose of NX-5948/placebo coadministered on Day 4
Period 1: NX-5948 or placebo administered under fasted conditions Period 2: NX-5948 or placebo administered under fed conditions Period 3: Fluconazole and single dose of NX-5948/placebo coadministered on Day 4
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nurix Therapeutics, Inc.
Lead Sponsor
Citations
A Study of NX-5948 in Adults With Relapsed/Refractory B- ...
Phase 1a is a dose escalation to evaluate the safety and tolerability of NX-5948 in adult patients with relapsed/refractory (R/R) B cell malignancies who ...
The Highly Potent and CNS-Active NX-5948 Shows BTK ...
NX-5948 is an orally bioavailable heterobifunctional degrader of BTK from Nurix currently in Ph. 1 trials for multiple B cell malignancies.
News - bexobrutideg (NX-5948)
bexobrutideg (NX-5948). 11ms. A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects (clinicaltrials.gov). P1, N ...
First Disclosure of NX-5948, an Oral Targeted Degrader of ...
NX-5948 is an oral, first-in-class, selective BTK degrader for B-cell malignancies, showing positive clinical activity and potent BTK ...
A phase I trial assessing the safety, pharmacokinetics ...
This phase I trial in healthy volunteers evaluated the safety and pharmacokinetics of tolebrutinib taken with food and during fasting and at ...
NX-5948 Study in Healthy Subjects · Info for Participants
What safety data is available for NX-5948? The provided research does not contain any safety data for NX-5948, compound 195, or NX5948. The studies ...
7.
ir.nurixtx.com
ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-results-ongoing-clinical-0Press releases
NX-5948 demonstrated a tolerable safety profile, and the safety profile for patients with WM was consistent with the safety profile for the ...
A Study of NX-5948 in Adults With Relapsed/Refractory B- ...
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced ...
Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) ...
NX-5948 is a novel, orally administered, small molecule that induces specific degradation of wild-type and mutant forms of BTK by ubiquitination ...
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