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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:June 2014
End Date:August 2015

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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

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.


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

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
We found this trial at
3
sites
Glendale, California 91206
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Glendale, CA
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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Minneapolis, MN
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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