CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 62 enrolled
Drug / intervention
LY3009104 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01536951
NCT01536951Phase 1Completed

A Placebo-Controlled, Single Dose, Dose Escalation (Part A) and a Placebo- and Positive-Controlled Study of the Effect on the Electrocardiographic QT Interval of a Single Dose (Part B) of LY3009104 in Healthy Subjects

Eli Lilly and Company·interventional·Posted Feb 22, 2012·Updated Jun 6, 2017

In Brief

A Phase 1 clinical trial evaluating LY3009104, Placebo, and 1 other intervention for Healthy Participants. Completed, enrolled 62 participants across 1 site.

Detailed Summary

This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females. Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected. Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsIncyte Corporation

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.4 years ago

Interventions

LY3009104drug

administered orally

Placebodrug

Administered orally

moxifloxacindrug

Administered orally