NCT06691828

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

A Phase 1, Open-Label, 2-Period, Fixed-Sequence Study to Assess the Absolute Bioavailability, Absorption, Metabolism, Excretion, and Mass Balance of [14C]-NX-5948 in Healthy Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Nurix Therapeutics, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

In Period 1 all subjects will receive a single dose of NX-5948 by IV and undergo pre and post dose labs to assess PK (pharmacokinetics) and PD parameters. In Period 2 all subjects will receive a single dose of NX-5948 by mouth. Pre and post dose blood, urine, and feces will be collected until NX-5948 is no longer identified in samples. Periods 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	NX-5948	NX-5948 will be given once by IV and then given once by mouth.

Timeline

• Start date: 2024-11-01
• Primary completion: 2024-11-28
• Completion: 2024-12-05
• First posted: 2024-11-15
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study