CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
LY3113593 +3 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/NCT02144285
NCT02144285Phase 1Completed

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Healthy Subjects and Patients With Chronic Kidney Disease Treated With Hemodialysis

Eli Lilly and Company·interventional·Posted May 21, 2014·Updated Jan 22, 2019

In Brief

A Phase 1 clinical trial evaluating LY3113593 and Placebo for Kidney Failure, Chronic. Completed, enrolled 64 participants across 3 sites.

Detailed Summary

The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.1 years ago

Interventions

LY3113593drug

Administered IV

LY3113593drug

Administered SC

Placebodrug

Administered IV

Placebodrug

Administered SC