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

NCT06717269 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NX-5948-304
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Assessment of PK parameters: NX-5948 tablets versus capsules

  Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (AUC)

  9 weeks

• Assessment of PK parameters: NX-5948 tablets versus capsules

  Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Cmax)

  9 weeks

• Assessment of PK parameters NX-5948 tablets versus capsules

  Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Tmax)

  9 weeks

• Food effect and effect of esomeprazole on AUC0-t for single-dose NX-5948 tablet

  Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet

  9 weeks

• Food effect and effect of esomeprazole on AUC0-inf for single-dose NX-5948 tablet

  Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet

  9 weeks

• Food effect and effect of esomeprazole on Cmax for single-dose NX-5948 tablet

  Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet

  9 weeks

Study Arms (2)

NX-5948 tablet and capsule under fasted and fed conditions

EXPERIMENTAL

Drug: NX-5948

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

EXPERIMENTAL

Drug: NX-5948; Drug: Esomeprazole

Interventions

NX-5948 DRUG

Administered orally in tablet or capsule form

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

Esomeprazole DRUG

Administered orally in capsule form

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

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

RECRUITING

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Study Director

  Nurix Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Angie Badgett, MBA

CONTACT

402-437-6351; angie.badgett@celerion.com

Allen Hunt, MD

CONTACT

402-437-6351; allen.hunt@celerion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: November 30, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)