NX-5948 for Healthy Subjects

Overseen By Angie Badgett, MBA

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Nurix Therapeutics, Inc.

Must not be taking: Antidepressants, Acid reducers, others

Disqualifiers: Cardiovascular disease, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

32 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study. Part 2 is a single-period PK evaluation study.

Research Team

Sarah Injac, MD PhD

Principal Investigator

Nurix Therapeutics, Inc.

Eligibility Criteria

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

I haven't smoked or used nicotine products for at least 3 months.

Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit

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

Exclusion Criteria

Positive Coronavirus disease 2019 (COVID-19) results at first check-in

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

I do not have any major health issues that could affect the study results or increase my risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

9 weeks

Multiple visits for dosing and monitoring

Part 2: Pharmacokinetics Evaluation

Participants receive NX-5948 or placebo to assess pharmacokinetics following 2 doses given 12 hours apart.

6 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Part 2: NX-5948 PK Experimental Treatment 2 Interventions

Experimental: Part 2: NX-5948 PK NX-5948 or placebo administered 2 doses given 12 hours apart under fasted conditions

Group II: Part 1: Sequence 2 (Treatment B, A, C) Experimental Treatment 2 Interventions

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

Group III: Part 1: Sequence 1 (Treatment A, B, C) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Nurix Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+