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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06486558
Brief Summary:
This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.
Detailed Description:
This is a 2-part study. Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Forty subjects will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) or capsule (reference) formulation in the fasted state. Fourteen days will separate dosing in Period 1 and Period 2. After Part 1 is completed, the Part 1 pharmacokinetic blood samples will be shipped for bioanalysis. Study conduct will proceed to Part 2. Fourteen days will separate dosing in Part 1 Period 2 and Part 2 Period 1.
Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2
Study:
NCT06486558
Study Brief:
Protocol Section:
NCT06486558