A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers

July 24, 2026 updated by: Nurix Therapeutics, Inc.

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (Actual)

223

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85283
        • Celerion
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, or vital signs at the screening visit, as deemed by the Principal Investigator (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.

Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: Placebo
Administered orally matching NX-5948 tablets
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Experimental: NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: Esomeprazole
Administered orally in capsule form
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Experimental: NX-5948 with and without famotidine under fasting and fed conditions
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Drug: Famotidine
Administered orally in tablet form
Experimental: Midazolam with and without NX-5948
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Drug: Midazolam
Administered orally in syrup form
Experimental: Digoxin with and without NX-5948
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Drug: Digoxin
Administered orally in tablet form
Experimental: Rosuvastatin with and without NX-5948
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Drug: Rosuvastatin
Administered orally in tablet form
Experimental: NX-5948 with and without quinidine
Drug: NX-5948
Administered orally in tablet or capsule form
Other Names:
  • Bexobrutideg
Drug: NX-5948
Administered in capsule form
Other Names:
  • Bexobrutideg
Drug: Quinidine
Administered orally in tablet form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948
Time Frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
9 weeks
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf): NX-5948
Time Frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
9 weeks
Maximum observed concentration (Cmax): NX-5948
Time Frame: 9 weeks
NX-5948 administered as a tablet or capsule under fasting and fed conditions; with and without esomeprazole, famotidine, or quinidine
9 weeks
AUC0-t: Midazolam, rosuvastatin, or digoxin
Time Frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
9 weeks
AUC0-inf: Midazolam, rosuvastatin, or digoxin
Time Frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
9 weeks
Cmax: Midazolam, rosuvastatin, or digoxin
Time Frame: 9 weeks
Midazolam, rosuvastatin, or digoxin administered with and without NX-5948
9 weeks
Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram
Time Frame: Baseline, 9 weeks
Baseline, 9 weeks
Number of participants with treatment-emergent adverse events
Time Frame: Up to 10 weeks
Up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nurix Therapeutics, Inc.

Investigators

  • Study Director: Study Director, Nurix Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2024

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 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)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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