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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT02238834
Brief Summary:
This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.
Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).
Detailed Description:
In the SAD part of the study the investigational drug will be administered once in a dose escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug will be orally taken as capsules. In the MAD part of the study the investigational drug will be administrated twice daily for 5 days depending on the half-life of FP-025, as determined in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either placebo or FP-025 in every cohort of the SAD and MAD part of the study.
Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).
Study:
NCT02238834
Study Brief:
Protocol Section:
NCT02238834