A Study of LY2409021 in Participants With Different Levels of Kidney Function
Condition: Kidney Failure, Chronic; Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Intervention: LY2409021
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to measure how much of the study drug, LY2409021, gets into the
      blood stream and how long it takes the body to get rid of it when given to participants with
      different levels of kidney function. There were five study groups. Each participant only
      enrolled in one group. Participants in groups 1 through 4 were healthy or have mild,
      moderate, or severe kidney disease. They completed one study period lasting about 29 days.
      Study group 5 enrolled participants with kidney disease who were on dialysis. They have
      completed two study periods which together last about 59 days. Screening was required within
      21 days prior to the start of the study for all participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria for ALL Participants

          -  Male participants must agree to use a reliable method of birth control in addition to
             having their partner use another method for the duration of the study and for 3 months
             after the last dose of LY2409021

          -  Female participants must not be of child-bearing potential

          -  Participants have a body mass index (BMI) of 18 to 40 kilogram per meter square
             (kg/m^2), inclusive, at screening

        Additional Inclusion Criteria for Control (Healthy) Participants

        - Control participants must have normal renal function, assessed by mean estimated
        creatinine clearance (CLcr) greater than or equal to (≥)90 milliliter per minute (mL/min)
        at screening and day before dosing

        Additional Inclusion Criteria for Participants with Mild-to-Severe Renal Impairment or End
        Stage Renal Disease (ESRD)

        - Males or females with stable mild-to-severe renal impairment, assessed by estimated CLcr,
        or with ESRD requiring hemodialysis (or hemodiafiltration) for at least 3 months

        Additional Inclusion Criteria for Participants with Type 2 Diabetes Mellitus (T2DM)

        - Participants with T2DM that are being treated with diet or exercise alone or receive
        treatment with insulin

        Exclusion Criteria:

        Exclusion Criteria for ALL Participants

          -  Participants that require peritoneal dialysis

          -  Participants that have a current, functioning, organ transplant

          -  Participants who show evidence of significant active uncontrolled endocrine or
             autoimmune abnormalities (for example, thyroid disease, pernicious anemia) as judged
             by the screening physician

          -  Participants who had a febrile illness within 3 days prior to screening

          -  Participants with an abnormality in the 12-lead Electrocardiogram (ECG) that, in the
             opinion of the investigator, increases the risks associated with participating in the
             study. [Participants with a QT interval corrected using Fridericia's (QTcF) formula
             >450 millisecond (msec) or a PR interval >0.22 sec on the screening ECG, or who have
             risk factors for Torsades de Pointes]

          -  Participants who show evidence of significant active neuropsychiatric disease

          -  Participants that are currently using or intend to use potent inhibitors of cytochrome
             P450 (CYP)3A, which include but are not limited to atazanavir, indinavir, nelfinavir,
             ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and
             telithromycin

          -  Participants who are currently using drugs with a narrow therapeutic index (for
             example, digoxin,lithium, phenytoin, theophylline, and warfarin)

          -  Participants that are currently using drugs that are known to prolong the QT interval

        Additional Exclusion Criteria for Participants with Mild, Moderate or Severe Renal
        Impairment or ESRD:

          -  Participants that have used any drug indicated for medical care of the participant's
             renal impairment, which is not established in dose and administered for at least 7
             days before LY2409021 administration

          -  Participants with poorly controlled hypertension (systolic blood pressure (BP) less
             than (>)160, diastolic BP >95 mm Hg) and/or evidence of labile blood pressure
             including symptomatic postural hypotension

          -  Participants with hemoglobin <9 grams per deciliter (g/dL) or significant active
             hematologic disease from causes other than underlying renal disease

        Additional Exclusion Criteria for Participants with T2DM:

          -  Participants who use an oral or injectable antihyperglycemic agent, except for
             insulin, within 1 month prior to dosing (Day 1)

          -  Participants who have experienced a ketoacidotic episode (pH <7.3) requiring
             hospitalization in the last 6 months