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

A Phase 1, Open-Label Study in Healthy Volunteers to Evaluate the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, and the Effect of Food and an Acid-reducing Agent on the Pharmacokinetics of NX-5948

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: NX-5948; Drug: Esomeprazole

Detailed Description

In Cohort 1, Period 1 volunteers will receive NX-5948 in a tablet form under fasting conditions. In Period 2, volunteers will receive NX-5948 in a capsule form under fasting conditions. In Period 3, volunteers will receive NX-5948 in a tablet form under fed conditions.

In Cohort 2, Period 1 volunteers will receive NX-5948 in a capsule form under fasting conditions. In Period 2, volunteers will receive NX-5948 in a tablet form under fasting conditions. In Period 3, esomeprazole will be administered once daily for 5 consecutive days with a single dose of NX-5948 tablet coadministered on Day 5.

In both cohorts, serial blood samples will be collected to assess PK.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Angie Badgett, MBA; Phone Number: 402-437-6351; Email: angie.badgett@celerion.com
• Study Contact Backup: Name: Allen Hunt, MD; Phone Number: 402-437-6351; Email: allen.hunt@celerion.com

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Recruiting
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NX-5948 tablet and capsule under fasted and fed conditions	Drug: NX-5948; Administered orally in tablet or capsule form
Experimental: NX-5948 tablet and capsule combined with esomeprazole under fasted conditions	Drug: NX-5948; Administered orally in tablet or capsule form; Drug: Esomeprazole; Administered orally in capsule form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nurix Therapeutics, Inc.
• Investigators: Study Director: Study Director, Nurix Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole; Esomeprazole
• Other Study ID Numbers: NX-5948-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No