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

Nurix Therapeutics, Inc.1 site in 1 country18 target enrollmentNovember 30, 2024

ConditionsHealthy Volunteer

InterventionsNX-5948 Esomeprazole

Overview

Phase: Phase 1
Intervention: NX-5948
Conditions: Healthy Volunteer
Sponsor: Nurix Therapeutics, Inc.
Enrollment: 18
Locations: 1
Primary Endpoint: Assessment of PK parameters NX-5948 tablets versus capsules
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

November 30, 2024

End Date

August 1, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nurix Therapeutics, Inc.

Responsible Party

Sponsor

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.