At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 39 enrolled
Drug / intervention
LY2484595 Reference Formulation (RF) +1 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.
Single Dose LY2484595 Tablet Formulations to Determine the Impact of Dose Level, Food, and Ethnicity on the Pharmacokinetics in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating LY2484595 Reference Formulation (RF) and LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) for Healthy Volunteers. Completed, enrolled 39 participants across 1 site.
Detailed Summary
The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects, and first-generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal, and after eating a high-fat meal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedOct 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.7 years ago
Interventions
LY2484595 Reference Formulation (RF)drug
Administered orally
LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)drug
Administered orally