Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006441

Trial Description

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Title

Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is 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 are five study groups. Each participant may
only enroll in one group. Participants in groups 1 through 4 may be healthy or may have
mild, moderate, or severe kidney disease. They will complete one study period lasting about
29 days. Study group 5 will enroll participants with kidney disease who are on dialysis.
They will complete two study periods which together last about 59 days. Screening is
required within 21 days prior to the start of the study for all participants.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006441
  •   2015/02/17
  •   2013/08/22
  •   no
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Secondary IDs

  •   NCT01929109  (ClinicalTrials.gov)
  •   14578  (Eli Lilly and Company)
  •   I1R-MC-GLBT 
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Health Condition or Problem studied

  •   Kidney Failure, Chronic
  •   Renal Insufficiency, Chronic
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: LY2409021
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Basic research/physiological study
  •   Parallel
  •   I
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Primary Outcome

- Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021; time frame: Predose up to 336 hours post dose in each period
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021; time frame: Predose up to 336 hours post dose in each period

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Secondary Outcome

- Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 in Participants with ESRD Before and After Dialysis; time frame: Group 5: Predose up to 336 hours post dose in each period
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 In Participants with ESRD Before and After Dialysis; time frame: Group 5: Predose up to 336 hours post dose in each period

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Countries of Recruitment

  •   Germany
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/08/31
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional 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

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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

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Addresses

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    • Eli Lilly and Company
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    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) 
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    • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 
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    •   1-317-615-4559
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.