RecruitingPhase 1NCT06717269

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

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

Sponsor

Nurix Therapeutics, Inc.

Enrollment

18 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

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.

Eligibility

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria5

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 Criteria19

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.