A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis
Condition: Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Intervention: LY3113593; LY3113593; Placebo; Placebo
Intervention description: Administered IV; Administered SC; Administered IV; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Renal dialysis

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.
    

Eligibility criteria:

        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