Clinical Trials Directory

Trials / Completed

CompletedNCT01460381

A Study to Evaluate the Effect of Genotype on LY2216684

A Study to Investigate the Effect of CYP2C19 Phenotype on the Pharmacokinetics of LY2216684 in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented.

Detailed description

The human cytochrome P450 2C19 (CYP2C19) enzyme is a polymorphic enzyme yielding ultrarapid metabolizer, extensive metabolizer (EM), intermediate metabolizer, and poor metabolizer (PM) phenotypes. Enrollment in the study was limited to participants predicted to be CYP2C19 extensive metabolizers or CYP2C19 poor metabolizers, as determined by genotyping analysis.

Conditions

Interventions

TypeNameDescription
DRUGLY2216684
DRUGQuinidine

Timeline

Start date
2011-10-01
Primary completion
2012-08-01
Completion
2012-08-01
First posted
2011-10-26
Last updated
2018-10-26
Results posted
2018-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01460381. Inclusion in this directory is not an endorsement.