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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01929109
First received: August 22, 2013
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Drug: LY2409021
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 [ Time Frame: Predose up to 336 hours post dose in each period ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 [ Time Frame: Predose up to 336 hours post dose in each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2409021 Mild Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
Drug: LY2409021
Administered orally
Experimental: LY2409021 Moderate Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
Drug: LY2409021
Administered orally
Experimental: LY2409021 Severe Renal Impairment
Participants will receive 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 will receive 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
Experimental: LY2409021 Control
Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
Drug: LY2409021
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929109

Locations
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
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01929109     History of Changes
Other Study ID Numbers: 14578, I1R-MC-GLBT
Study First Received: August 22, 2013
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014