Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT01263093
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2010-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pharmacokinetic Study on the Effect of LY2216684 on the Active Metabolite of Clopidogrel
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Effect of LY2216684 on the Pharmacokinetics and Pharmacodynamics of R-130964, the Active Metabolite of Clopidogrel, in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-03
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 of the study drugs (clopidogrel and LY2216684) reach the blood stream and how long it takes the body to dispose of them and to determine how clopidogrel and LY2216684 might affect each other in the body. Information about any side effects that may occur will also be collected.
Detailed Description:
Clopidogrel is rapidly converted to R-130964 by the enzyme cytochrome P450 2C19 (CYP2C19). Enrollment in the study was limited to participants with specific genotypes of the CYP2C19 gene, including the \*1/\*1 genotype (CYP2C19 extensive metabolizers) and the \*1/\*17 or \*17/\*17 genotypes (CYP2C19 ultra-rapid metabolizers). All primary and secondary objectives were limited to participants with the CYP2C19\*1/\*1 genotype.
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 |
|---|---|---|---|---|
| H9P-EW-LNBY | OTHER | Eli Lilly and Company | View |