Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT02818335
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2016-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3023414 Formulations and the Effect of Food
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-11
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 purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical conditions.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| I6A-EW-CBBB | OTHER | Eli Lilly and Company | View |