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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04223960
Brief Summary:
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
Detailed Description:
The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe and well-tolerated dose in healthy Caucasian and Japanese male participants. The study consists of 2 parts as mentioned below:
Part A: This part of the study is fully adaptive and will be performed in three sub-parts as follows:
* Single ascending dose (SAD)
* Food Effect (FE) and optional bioavailability
* Multiple ascending dose (MAD)
Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:
* SAD
* An additional FE period in SAD cohorts (SAD-FE)
* Food Effect and bioavailability (FE/BA)
* MAD
Study:
NCT04223960
Study Brief:
Protocol Section:
NCT04223960