RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.

Official Title

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

Quick Facts

Study Start:2024-11-30

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06717269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Angie Badgett, MBA

CONTACT

402-437-6351

angie.badgett@celerion.com

Allen Hunt, MD

CONTACT

402-437-6351

allen.hunt@celerion.com

Principal Investigator

Study Director

STUDY_DIRECTOR

Nurix Therapeutics

Study Locations (Sites)

Celerion

Lincoln, Nebraska, 68502

United States

Collaborators and Investigators

Sponsor: Nurix Therapeutics, Inc.

Study Director, STUDY_DIRECTOR, Nurix Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-30

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-11-30

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteer