Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06593457
Brief 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.
Study:
NCT06593457
Study Brief:
Protocol Section:
NCT06593457