32 Participants Needed

NX-5948 for Healthy Subjects

AB
Overseen ByAngie Badgett, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

SI

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
See 3 more

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.
See 4 more

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
3Treatment groups
Experimental Treatment
Group I: Part 2: NX-5948 PKExperimental Treatment2 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 Treatment2 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 Treatment2 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nurix Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
1,100+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security