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

NCT ID: NCT06717269

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-03-31

Brief Summary

This is a 2-cohort, fixed-sequence, 3-period, relative bioavailability, food-effect, and drug-drug interaction study. It is an open-label study evaluating the relative bioavailability of NX-5948 tablets compared to capsules, and the effect of food and an acid-reducing agent on the pharmacokinetics (PK) of NX-5948.

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NX-5948 tablet and capsule under fasted and fed conditions

Cohort 1: Single dose of NX-5948 tablet under fasted and fed conditions. Also, single dose of NX-5948 capsule under fasted conditions.

Group Type: EXPERIMENTAL

NX-5948 capsule

Intervention Type: DRUG

NX-5948 in capsule form

NX-5948 tablet

Intervention Type: DRUG

NX-5948 in tablet form

NX-5948 tablet combined with esomeprazole under fasted conditions

Cohort 2: Single dose of NX-5948 tablet combined with esomeprazole under fasted conditions. Also, a single dose of NX-5948 capsule under fasted conditions.

Group Type: EXPERIMENTAL

NX-5948 capsule

Intervention Type: DRUG

NX-5948 in capsule form

NX-5948 tablet

Intervention Type: DRUG

NX-5948 in tablet form

Esomeprazole

Intervention Type: DRUG

Esomeprazole capsule, once daily

Interventions

NX-5948 capsule

NX-5948 in capsule form

Intervention Type: DRUG

NX-5948 tablet

NX-5948 in tablet form

Intervention Type: DRUG

Esomeprazole

Esomeprazole capsule, once daily

Intervention Type: DRUG

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.
• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nurix Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Injac, MD

Role: STUDY_DIRECTOR

Nurix Therapeutics

Locations

Celerion

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angie Badgett, MBA

Role: CONTACT

Phone: 402-437-6351

Email: angie.badgett@celerion.com

Allen Hunt, MD

Role: CONTACT

Phone: 402-437-6351

Email: allen.hunt@celerion.com

Other Identifiers

NX-5948-304

Identifier Type: -

Identifier Source: org_study_id