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

NCT06593457 | Completed Phase 1 FDA Drug

• 1 other identifier: NX-5948-302
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Drug-Drug Interaction; Food effects; Healthy participants; Pharmacokinetics; Pharmacodynamics; NX-5948; BTK Degrader

Outcome Measures

Primary Outcomes (9)

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

  To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.

  9 weeks

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

  To evaluate the effect of food on the single-dose pharmacokinetics (PK) of NX-5948 in healthy subjects.

  Approximately 9 weeks

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

  To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

  9 weeks

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

  To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

  9 weeks

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

  To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

  9 weeks

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

  To evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects.

  Approximately 9 weeks

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

  To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

  6 weeks

• Part 2 PK: Cmax for NX-5948 administration

  To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

  6 weeks

• Part 2 PK: AUC0-t for NX-5948 administration

  To evaluate the PK of NX-5948 following 2 doses of NX-5948 given 12 hours apart in healthy subjects.

  Approximately 6 weeks

Secondary Outcomes (2)

• Part 1: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Approximately 9 weeks

• Part 2: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Approximately 6 weeks

Study Arms (3)

Part 1: Sequence 1 (Treatment A, B, C)

EXPERIMENTAL

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

Drug: IP; Drug: Matching Placebo

Part 1: Sequence 2 (Treatment B, A, C)

EXPERIMENTAL

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

Drug: IP; Drug: Matching Placebo

Part 2: NX-5948 PK

EXPERIMENTAL

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

Drug: IP; Drug: Matching Placebo

Interventions

IP DRUG

NX-5948 oral

Part 1: Sequence 1 (Treatment A, B, C); Part 1: Sequence 2 (Treatment B, A, C); Part 2: NX-5948 PK

Matching Placebo DRUG

Fluconazole

Part 1: Sequence 1 (Treatment A, B, C); Part 1: Sequence 2 (Treatment B, A, C); Part 2: NX-5948 PK

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Patients must be assigned the male gender at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 participation in the study.
• History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds.
• History or presence of:
• Significant multiple and/or severe allergies, including anaphylactic reaction.
• Risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome, or sudden unexpected cardiac death at a young age).
• Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
• Myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, clinically significant ventricular or atrial tachyarrhythmia as determined by the PI or designee, documented syncope without identified and corrected cause, a pacemaker or implantable cardioverter-defibrillator, cardiac or carotid/cerebral stent placement or angioplasty, or clinically significant valvular heart disease.
• Adrenal insufficiency.
• Skin infection.
• 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.
• Unable to refrain from or anticipates the use of:
• Any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements (including kava, ginko biloba, yohimbe, and saw palmetto) beginning 14 days prior to the first dosing.
• Any drugs known to be moderate or strong inducers and inhibitors of CYP3A4, P gp, and/or breast cancer resistance protein, including St. John's Wort, dehydroepiandrosterone, and ginseng, beginning 28 days prior to the first dosing.

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Sarah Injac, MD PhD

  Nurix Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion: October 29, 2024
• Study Completion: November 14, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)