NX-5948 Bioavailability Study in Healthy Subjects

Overseen By Allen Hunt, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Nurix Therapeutics, Inc.

Disqualifiers: Psychiatric, Cardiovascular, Gastrointestinal, others

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

Compensation: Varies

Number of Visits: 6

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs a new treatment called NX-5948 and how food and another drug influence this absorption. The study compares the effects of NX-5948 when taken as a tablet versus a capsule. Participants are healthy non-smokers without significant medical issues, interested in understanding how different conditions affect the drug's performance. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be medically healthy with no significant medical history. This suggests that participants should not be on any regular medications for ongoing health issues.

Is there any evidence suggesting that NX-5948 is likely to be safe for humans?

Research has shown that NX-5948, the treatment under study, has been tested in earlier trials. These studies have assessed its safety in individuals with certain types of blood cancer. Most participants tolerated the treatment well, with no serious issues reported. Some minor side effects occurred but were generally manageable.

The trial available for participation is in an early phase, focusing heavily on safety. At this stage, researchers closely monitor participants' reactions to the treatment. It's important to note that the full safety profile is not yet completely understood due to the trial's early phase. However, progression to this phase suggests promising earlier safety checks.

For those considering participation, earlier participants have generally tolerated NX-5948 without major problems. Discuss any concerns with the study team and ensure all questions are answered before making a decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about NX-5948 because it offers a unique approach to enhancing drug absorption in the body. Unlike standard treatments that might have limitations with absorption, NX-5948 is being tested in both tablet and capsule forms under various conditions to understand its bioavailability, which is how well and how quickly the drug is absorbed. The study also examines the impact of combining it with esomeprazole, a medication that reduces stomach acid, to see if this further enhances absorption. This focus on maximizing bioavailability could lead to more effective dosing and improved patient outcomes.

What evidence suggests that NX-5948 could be effective?

Research has shown that NX-5948 yields promising results for treating certain blood cancers. In one study, 77.8% of patients with Waldenstrom's demonstrated positive responses to the drug. This suggests that NX-5948 could effectively target specific cancer cells. The treatment blocks a protein called Bruton's Tyrosine Kinase (BTK), which aids the growth of some cancer cells. While current research focuses on cancer treatment, this trial will examine the bioavailability of NX-5948 in healthy subjects under different conditions, highlighting its potential effectiveness. ^{4 5 6 7 8}

Who Is on the Research Team?

Sarah Injac, MD

Principal Investigator

Nurix Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy individuals. It's designed to understand how the body absorbs a new medication, NX-5948, in tablet versus capsule form and how food or an acid-reducing drug like Esomeprazole affects this process.

Inclusion Criteria

I am a healthy adult between 19 and 55 years old.

Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

Exclusion Criteria

Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit

Plasma donation within 7 days prior to the first dosing

History or presence of significant multiple and/or severe allergies, including anaphylactic reaction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Cohort 1

Participants receive NX-5948 in tablet and capsule forms under fasted and fed conditions

3 weeks

3 visits (in-person)

Treatment - Cohort 2

Participants receive NX-5948 in tablet and capsule forms with esomeprazole under fasted conditions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NX-5948

Trial Overview The study tests the absorption (bioavailability) of NX-5948 when taken as a tablet compared to a capsule. Participants will also see how taking it with food or alongside Esomeprazole alters its absorption into the body.

How Is the Trial Designed?

Group I: NX-5948 tablet combined with esomeprazole under fasted conditions Experimental Treatment 3 Interventions

Cohort 2: Single dose of NX-5948 tablet combined with esomeprazole under fasted conditions. Also, a single dose of NX-5948 capsule under fasted conditions.

Group II: NX-5948 tablet and capsule under fasted and fed conditions Experimental Treatment 2 Interventions

Cohort 1: Single dose of NX-5948 tablet under fasted and fed conditions. Also, single dose of NX-5948 capsule under fasted conditions.

Who Is Running the Clinical Trial?

Nurix Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Citations

1. ir.nurixtx.com ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-results-ongoing-clinical-0

Press releases NX-5948 demonstrated robust clinical activity with objective responses observed in 7 of 9 (77.8%) evaluable Waldenstrom's patients in the ongoing Phase 1a/1b ...

2. drughunter.com drughunter.com/molecule/nx-5948

The Highly Potent and CNS-Active NX-5948 Shows BTK ... This case study breaks down the discovery story of NX-5948, its impressive early clinical results, and what this compound's early success could ...

3. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper194839.html

Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) ... Conclusions: These findings demonstrate that NX-5948 remains well tolerated in pts with CLL, with no clinically meaningful changes in safety ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05131022

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 ...

5. ir.nurixtx.com ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-results-ongoing-clinical

Press releases Nurix Therapeutics presents positive results from ongoing clinical trial of NX-5948 in patients with relapsed refractory chronic lymphocytic leukemia (CLL).

6. nurixtx.com nurixtx.com/wp-content/uploads/2024/04/NX-5948-BSH-ePoster-03_22_2024.pdf

NX-5948, a selective BTK degrader NX-5948-301 is a Phase 1, first-in-human, dose-escalation and cohort-expansion trial evaluating the safety, tolerability, and clinical activity ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05131022

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 ...

8. ash.confex.com ash.confex.com/ash/2023/webprogram/Paper179508.html

4473 Initial Findings from a First-in-Human Phase ... Here we provide the first disclosure of preliminary safety and efficacy findings from a Phase 1a trial of NX-5948 in patients with relapsed/ ...