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Celerion | Lincoln Celerion CPU

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

N

Nurix Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Esomeprazole
Drug: NX-5948 tablet
Drug: NX-5948 capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT06717269
NX-5948-304

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

NX-5948 tablet and capsule under fasted and fed conditions
Experimental group
Description:
Cohort 1: Single dose of NX-5948 tablet under fasted and fed conditions. Also, single dose of NX-5948 capsule under fasted conditions.
Treatment:
Drug: NX-5948 capsule
Drug: NX-5948 tablet
NX-5948 tablet combined with esomeprazole under fasted conditions
Experimental group
Description:
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.
Treatment:
Drug: NX-5948 capsule
Drug: NX-5948 tablet
Drug: Esomeprazole

Trial contacts and locations

1

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Central trial contact

Allen Hunt, MD; Angie Badgett, MBA

Data sourced from clinicaltrials.gov

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