CompletedPhase 1

A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects

United States32 participantsStarted 2024-08-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study: * Healthy, adult, male, 18-55 years of age * Subjects must follow protocol-specified contraception guidance as described in the protocol. * Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting. * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and 12-lead safety ECGs, at the screening visit and/or first check-in, as deemed by the PI or designee, * Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol. Key Exclusion Criteria: Subjects must not be enrolled in the study if they meet any of the following criteria: * Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic (including leukemia, lymphoma, malignant melanoma), myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders, or any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subjects by their partici…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions

Timeframe: 9 weeks

Part 1 Food Effect: AUC0-inf for NX-5948 administered under fed and fasted conditions

Timeframe: Approximately 9 weeks

Part 1 Food Effect: Cmax for NX-5948 administered under fed and fasted conditions

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: AUC0-inf for NX-5948 administered with and without fluconazole

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: Cmax for NX-5948 administered with and without fluconazole

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: AUC0-t for NX-5948 administered with and without fluconazole

Timeframe: Approximately 9 weeks

Part 2 PK: AUC0-inf for NX-5948 administration

Timeframe: 6 weeks

Trial details

NCT IDNCT06593457

SponsorNurix Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1 Food Effect: AUC0-t for NX-5948 administered under fed and fasted conditions

Timeframe: 9 weeks

Part 1 Food Effect: AUC0-inf for NX-5948 administered under fed and fasted conditions

Timeframe: Approximately 9 weeks

Part 1 Food Effect: Cmax for NX-5948 administered under fed and fasted conditions

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: AUC0-inf for NX-5948 administered with and without fluconazole

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: Cmax for NX-5948 administered with and without fluconazole

Timeframe: 9 weeks

Part 1 Drug Drug Interaction: AUC0-t for NX-5948 administered with and without fluconazole

Timeframe: Approximately 9 weeks

Part 2 PK: AUC0-inf for NX-5948 administration

Timeframe: 6 weeks