Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance Study of [14C] NX-5948

NCT06691828 | Completed Phase 1 FDA Drug

• 1 other identifier: NX-5948-303
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, 2-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of \[14C\]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Period 2 will analyze total radioactivity and metabolite profiling.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (7)

• Characterize Area Under the Curve (AUC0-inf), Half-life (T1/2) after IV dosing of NX-5948

  Characterize the Area Under the Curve (AUC0-inf), Half-life (T1/2) of a single IV dose of NX-5948 in healthy adult male subjects.

  9 weeks

• Evaluation of metabolite after oral dosing with [14C]-NX-5948

  Identify major metabolite and its AUC in plasma following a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects.

  9 weeks

• Assessment of bioavailability with oral dosing of NX-5948

  Determine the absolute bioavailability (ABA) of an oral formulation of \[NX-5948C\]- in healthy adult male subjects.

  9 weeks

• Assessment of total radioactivity after oral dosing with NX-5948

  Determine the recovery of total radioactivity (TRA; mass balance) as a percentage of the administered dose after a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects.

  9 weeks

• Assessment of whole blood to plasma ratio for TRA after oral dosing with NX-5948

  Characterize whole blood to plasma ratio for TRA following a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects (i.e., whole blood:plasma partitioning ratio).

  9 weeks

• Characterize the Clearance (CL) after IV dosing of NX-5948

  Character the Clearance (CL) after IV dosing of NX-5948in healthy adults male subjects.

  9 weeks

• Characterize the Volume of distribution (Vz) after IV dosing of NX-5948

  Character the Volume of distribution (Vz) after IV dosing of NX-5948in healthy adults male subjects.

  9 weeks

Study Arms (1)

Active Treatment Arm IV and Oral

EXPERIMENTAL

This single Arm will include a single dose by IV and a single dose given by mouth for all 8 subjects.

Drug: NX-5948

Interventions

NX-5948 DRUG

NX-5948 will be given once by IV and then given once by mouth.

Active Treatment Arm IV and Oral

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: This study will enroll male subjects only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male, 18-55 years of age
• Subjects must follow protocol-specified contraception guidance as described in the protocol.
• Continuous non-smoker who has not used nicotine-and tobacco-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and 12-lead safety ECGs, at the screening visit and/or first check-in, 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.

You may not qualify if:

• Subjects must not be enrolled in the study if they meet any of the following criteria:
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic (including leukemia, lymphoma, malignant melanoma), myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders, or any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subjects by their participation in the study.
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
• 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.
• Any significant (as determined by the PI) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
• Has tattoo(s) or scarring at or near the site of IV injection or any other condition which may interfere with IV injection site examination, in the opinion of the PI or designee.
• Previous exposure to NX-5948.

Sponsors & Collaborators

• Nurix Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Sarah Injac, MD PhD

  Nurix Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 15, 2024
• Study Start: November 1, 2024
• Primary Completion: November 28, 2024
• Study Completion: December 5, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)