NX-5948 for Healthy Subjects
AB
Overseen ByAngie Badgett, MBA
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Nurix Therapeutics, Inc.
No Placebo Group
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
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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.
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Treatment Details
Interventions
- NX-5948 (Other)
Trial OverviewThe 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
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Who Is Running the Clinical Trial?
Nurix Therapeutics, Inc.
Lead Sponsor
Trials
7
Recruited
1,100+