Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets

NCT ID: NCT06717269

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-08-31

Brief Summary

This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NX-5948 tablet and capsule under fasted and fed conditions

Group Type: EXPERIMENTAL

NX-5948

Intervention Type: DRUG

Administered orally in tablet or capsule form

NX-5948 tablet and capsule combined with esomeprazole under fasted conditions

Group Type: EXPERIMENTAL

NX-5948

Intervention Type: DRUG

Administered orally in tablet or capsule form

Esomeprazole

Intervention Type: DRUG

Administered orally in capsule form

Interventions

NX-5948

Administered orally in tablet or capsule form

Intervention Type: DRUG

Esomeprazole

Administered orally in capsule form

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, adult, male or female 19-55 years of age
• Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead safety ECGs at the screening visit, 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.

Exclusion Criteria

• Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
• Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders
• History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948
• History or presence of alcohol or drug abuse within the past 2 years
• 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.
• Personal or family history of prolonged QT syndrome or family history of sudden cardiac death.
• Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff Parkinson-White Syndrome, or cardiac pacemaker.
• Adrenal insufficiency.
• Skin infection.
• Female volunteers of childbearing potential
• Female volunteer with a positive pregnancy test
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit
• Donation of blood or significant blood loss within 56 days prior to the first dosing
• Plasma donation within 7 days prior to the first dosing
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• Previous exposure to NX-5948.
• Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nurix Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Nurix Therapeutics

Locations

Celerion

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angie Badgett, MBA

Role: CONTACT

angie.badgett@celerion.com

402-437-6351

Allen Hunt, MD

Role: CONTACT

allen.hunt@celerion.com

402-437-6351

Other Identifiers

NX-5948-304

Identifier Type: -

Identifier Source: org_study_id