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A Study of LY2409021 in Participants With Different Levels of Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929109
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Renal Insufficiency, Chronic Drug: LY2409021 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Experimental: LY2409021 Control
Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
Drug: LY2409021
Administered orally

Experimental: LY2409021 Mild Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
Drug: LY2409021
Administered orally

Experimental: LY2409021 Moderate Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
Drug: LY2409021
Administered orally

Experimental: LY2409021 Severe Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
Drug: LY2409021
Administered orally

Experimental: LY2409021 End Stage Renal Disease
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
Drug: LY2409021
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose ]
  2. Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis [ Time Frame: Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose ]
  2. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis [ Time Frame: Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929109


Locations
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Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Munich, Germany, 81241
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01929109    
Other Study ID Numbers: 14578
I1R-MC-GLBT ( Other Identifier: Eli Lilly and Company )
First Posted: August 27, 2013    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases