NX-5948 Bioavailability Study in Healthy Subjects

Overseen By Allen Hunt, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Nurix Therapeutics, Inc.

Disqualifiers: Psychiatric, Cardiovascular, Gastrointestinal, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a 2-cohort, fixed-sequence, 3-period, relative bioavailability, food-effect, and drug-drug interaction study. It is an open-label study evaluating the relative bioavailability of NX-5948 tablets compared to capsules, and the effect of food and an acid-reducing agent on the pharmacokinetics (PK) of NX-5948.

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.

Research Team

Sarah Injac, MD

Principal Investigator

Nurix Therapeutics

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• NX-5948 (Other)

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.

Participant Groups

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+