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

Launched by NURIX THERAPEUTICS, INC. · Dec 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NX-5948 to understand how well it works when taken as a tablet compared to a capsule. The researchers want to see if eating food or taking a medicine that reduces stomach acid affects how the body processes NX-5948. This is important information that can help improve the use of this medication in future treatments.

To participate in this study, you need to be a healthy adult between the ages of 19 and 55, and you should not have any significant medical conditions or a history of substance abuse. Participants will need to be non-smokers and should be willing to follow the study rules. If you join the trial, you will receive the medication and be monitored to see how your body reacts to it under different conditions. It's a great opportunity to contribute to medical research while ensuring your health is closely observed throughout the process.

Gender

ALL

Eligibility 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.