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Clinical Trial Details

Trial ID: L0480
Source ID: NCT02144285
Associated Drug: Ly3113593
Title: A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02144285/results
Conditions: Kidney Failure, Chronic
Interventions: DRUG: LY3113593|DRUG: LY3113593|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section., Baseline through end of study (Day 85) | Secondary: Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593, Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593, Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios, Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593, Baseline, Day 85|Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593, Baseline, Day 85|Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593, Baseline, Day 85
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2014-06
Completion Date: 2015-08
Results First Posted: 2019-01-22
Last Update Posted: 2019-01-22
Locations: Parexel Early Phase Unit at Glendale, Glendale, California, 91206, United States|Orlando Clinical Research Center, Orlando, Florida, 32809, United States|Davita Clinical Research, Minneapolis, Minnesota, 55404, United States
URL: https://clinicaltrials.gov/show/NCT02144285