A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis

Phase 1

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Placebo; Drug: LY3113593

• Registration Number: NCT02144285
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Study Start: 2014-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-10-21
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Results First Posted: 2019-01-22
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Healthy Participants:

  • Healthy males or females
  • Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive at screening

• Participants Treated with Hemodialysis:

  • Participants are males or females who have end-stage renal disease (ESRD) and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening
  • Participants have a hemoglobin value greater than or equal to (≥)9.0 grams per deciliter (g/dL) and less than or equal to (≤)12.5 g/dL at screening
  • Participants have a body mass index (BMI) of 18.5 to 45.0 kg/m^2, inclusive, at screening

• Both Populations:

  • Male participants agree to use a reliable method of birth control and avoid donating sperm during the study and for 3 months following the dose of the investigational product
  • Female participants must not be of child-bearing potential

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Exclusion Criteria

• Healthy Participants:

  • Participants that have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Participants that have used or intend to use over-the-counter or prescription medication, including herbal medications within 14 days prior to dosing

• Participants Treated with Hemodialysis:

  • Participants that have a history of myocardial infarction, acute coronary syndrome, stroke or transient ischemic attacks within the prior 6 months
  • Participants that have heart failure that results in dyspnea at rest or during minimal exercise
  • Participants that have poorly controlled hypertension
  • Participants that have a history of significant thrombotic disease, pulmonary hypertension, significant hematological disease or current liver disease, known hepatic or biliary abnormalities
  • Participants that had a blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study
  • Participants that have evidence of active peptic, duodenal, or esophageal ulcer disease or gastrointestinal bleeding within the prior 12 weeks

• Both Populations:

  • Participants that have known allergies to related compounds or any components of the study drug or its formulation, clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions or history of significant atopy
  • Participants that have participated, within the last 30 days (or 5 half-lives if long half life) in a clinical trial involving an investigational product
  • Participants that have known or ongoing psychiatric disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo IV (Part B)	Placebo	Single dose of placebo matching LY3113593 administered IV
Placebo SC (Part A)	Placebo	Single dose of placebo matching LY3113593 administered SC
Placebo IV (Part A)	Placebo	Single dose of placebo matching LY3113593 administered IV
LY3113593 SC (Part A)	LY3113593	Single dose of LY3113593 administered subcutaneous (SC)
LY3113593 IV (Part B)	LY3113593	Single dose of LY3113593 administered IV
LY3113593 IV (Part A)	LY3113593	Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through end of study (Day 85)	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Davita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States

Parexel Early Phase Unit at Glendale; 🇺🇸 Glendale, California, United States