- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929109
A Study of LY2409021 in Participants With Different Levels of Kidney Function
Pharmacokinetics of LY2409021 Following Administration to Subjects With Varying Degrees of Renal Function
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Munich, Germany, 81241
- 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.
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Liverpool, United Kingdom, L7 8XP
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LY2409021 Control
Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
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Administered orally
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Experimental: LY2409021 Mild Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
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Administered orally
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Experimental: LY2409021 Moderate Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
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Administered orally
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Experimental: LY2409021 Severe Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
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Administered orally
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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.
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Administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
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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
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Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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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
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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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14578
- I1R-MC-GLBT (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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