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

NCT06717269 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NX-5948-304
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• Area under the concentration-time curve from time 0 to last observed non-zero concentration (AUC0-t): NX-5948

  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

  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

  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

  Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  9 weeks

• AUC0-inf: Midazolam, rosuvastatin, or digoxin

  Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  9 weeks

• Cmax: Midazolam, rosuvastatin, or digoxin

  Midazolam, rosuvastatin, or digoxin administered with and without NX-5948

  9 weeks

• Placebo-corrected change from baseline QT interval (QTc) as measured by electrocardiogram

  Baseline, 9 weeks

• Number of participants with treatment-emergent adverse events

  Up to 10 weeks

Study Arms (7)

NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo

EXPERIMENTAL

Drug: NX-5948; Drug: Placebo

NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions

EXPERIMENTAL

Drug: NX-5948; Drug: Esomeprazole

NX-5948 with and without famotidine under fasting and fed conditions

EXPERIMENTAL

Drug: Famotidine; Drug: NX-5948

Midazolam with and without NX-5948

EXPERIMENTAL

Drug: Midazolam; Drug: NX-5948

Digoxin with and without NX-5948

EXPERIMENTAL

Drug: Digoxin; Drug: NX-5948

Rosuvastatin with and without NX-5948

EXPERIMENTAL

Drug: Rosuvastatin; Drug: NX-5948

NX-5948 with and without quinidine

EXPERIMENTAL

Drug: Quinidine; Drug: NX-5948

Interventions

NX-5948 DRUG

Administered orally in tablet or capsule form

Also known as: Bexobrutideg

NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo; NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions

Esomeprazole DRUG

Administered orally in capsule form

NX-5948 tablet and capsule with and without esomeprazole under fasting and fed conditions

Placebo DRUG

Administered orally matching NX-5948 tablets

NX-5948 tablet and capsule under fasting and fed conditions; with and without placebo

Famotidine DRUG

Administered orally in tablet form

NX-5948 with and without famotidine under fasting and fed conditions

Midazolam DRUG

Administered orally in syrup form

Midazolam with and without NX-5948

Digoxin DRUG

Administered orally in tablet form

Digoxin with and without NX-5948

Rosuvastatin DRUG

Administered orally in tablet form

Rosuvastatin with and without NX-5948

Quinidine DRUG

Administered orally in tablet form

NX-5948 with and without quinidine

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, 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.

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 (2)

Celerion

Phoenix, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Esomeprazole; Famotidine; Midazolam; Digoxin; Rosuvastatin Calcium; Quinidine

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; Thiazoles; Azoles; Benzodiazepines; Benzazepines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Pyrimidines; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines

Study Officials

• Study Director

  Nurix Therapeutics

  STUDY DIRECTOR

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: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)