Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04223960
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
Sponsor:
EA Pharma Co., Ltd.
Organization:
Study Overview
Official Title:
A First-in-human, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Volunteers
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001886-34 | EUDRACT_NUMBER | None | View |