NCT06593457

A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects

A Phase 1, 2-Part, Placebo-Controlled, Double-Blinded Study to Assess the Effect of Food and Drug-Drug Interaction of Fluconazole on the Pharmacokinetics of NX-5948

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Nurix Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study. Part 2 is a single-period PK evaluation study.

Detailed description

Part 1: Periods 1 and 2: Subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio. In each treatment sequence, subjects will be randomized to receive either active NX-5948 or placebo in a 7:2 ratio. Subjects will receive a single dose of NX-5948 or placebo under fasting or fed conditions as per randomization schedule to evaluate the effect of food on the single- dose pharmacokinetics (PK) of NX-5948 in healthy subjects. Period 3: Fluconazole will be administered every day for 8 consecutive days with a single dose of NX-5948/placebo coadministered on Day 4 to evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects. Part 2: Subjects will be randomized to receive either active NX-5948 or placebo to assess single-period PK. Parts 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	IP	NX-5948 oral
DRUG	Matching Placebo	Fluconazole

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-10-29
• Completion: 2024-11-14
• First posted: 2024-09-19
• Last updated: 2025-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study