CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
LY3016859 intravenous +3 moredrug
Likely dose
LY3016859 intravenous or subcutaneous (dose not specified)AI-extracted
Key inclusion· 5
  • ✓Healthy men and women of non-childbearing potential
  • ✓Weight ≥50 kg at screening and dosing
  • ✓Clinical laboratory test results within normal reference range or acceptable deviations judged not clinically significant
  • ✓Sufficient venous access for blood sampling
Key exclusion· 10
  • ✕Enrolled in or discontinued investigational drug trial within last 60 days, or received biologic agents within 3 months or 5 half-lives prior to dosing
  • ✕Prior exposure to LY3016859
  • ✕Medical illness including cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease that would preclude participation
  • ✕QTcF >450 msec (men) or >470 msec (women), bundle branch blocks, irregular rhythms other than sinus arrhythmia, history of unexplained syncope, or family history of sudden cardiac death/long QT syndrome

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

Search/NCT01545583
NCT01545583Phase 1Completed
CompareCT.gov

Study of the Safety, Tolerability and Pharmacokinetics of LY3016859 After Single Intravenous and Subcutaneous Dosing in Healthy Volunteers

Eli Lilly and Company·interventional·Posted Mar 7, 2012·Updated Jul 19, 2018

In Brief

A Phase 1 clinical trial evaluating LY3016859 intravenous, Placebo intravenous, and 2 other interventions for Healthy Volunteers. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartApr 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.3 years ago

Interventions

LY3016859 intravenousdrug

Administered intravenously

Placebo intravenousdrug

Administered intravenously

LY3016859 subcutaneousdrug

Administered subcutaneously

Placebo subcutaneousdrug

Administered subcutaneously