- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144285
A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis
A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3113593 in Healthy Subjects and Patients With Chronic Kidney Disease Treated With Hemodialysis
The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body.
This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- Parexel Early Phase Unit at Glendale
-
-
Florida
-
Orlando, Florida, United States, 32809
- Orlando Clinical Research Center
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- DaVita Clinical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy Participants:
- Healthy males or females
- Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m^2), inclusive at screening
Participants Treated with Hemodialysis:
- Participants are males or females who have end-stage renal disease (ESRD) and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening
- Participants have a hemoglobin value greater than or equal to (≥)9.0 grams per deciliter (g/dL) and less than or equal to (≤)12.5 g/dL at screening
- Participants have a body mass index (BMI) of 18.5 to 45.0 kg/m^2, inclusive, at screening
Both Populations:
- Male participants agree to use a reliable method of birth control and avoid donating sperm during the study and for 3 months following the dose of the investigational product
- Female participants must not be of child-bearing potential
Exclusion Criteria:
Healthy Participants:
- Participants that have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Participants that have used or intend to use over-the-counter or prescription medication, including herbal medications within 14 days prior to dosing
Participants Treated with Hemodialysis:
- Participants that have a history of myocardial infarction, acute coronary syndrome, stroke or transient ischemic attacks within the prior 6 months
- Participants that have heart failure that results in dyspnea at rest or during minimal exercise
- Participants that have poorly controlled hypertension
- Participants that have a history of significant thrombotic disease, pulmonary hypertension, significant hematological disease or current liver disease, known hepatic or biliary abnormalities
- Participants that had a blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study
- Participants that have evidence of active peptic, duodenal, or esophageal ulcer disease or gastrointestinal bleeding within the prior 12 weeks
Both Populations:
- Participants that have known allergies to related compounds or any components of the study drug or its formulation, clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions or history of significant atopy
- Participants that have participated, within the last 30 days (or 5 half-lives if long half life) in a clinical trial involving an investigational product
- Participants that have known or ongoing psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3113593 IV (Part A)
Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels
|
Administered IV
Administered SC
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Placebo Comparator: Placebo IV (Part A)
Single dose of placebo matching LY3113593 administered IV
|
Administered SC
Administered IV
|
Experimental: LY3113593 SC (Part A)
Single dose of LY3113593 administered subcutaneous (SC)
|
Administered IV
Administered SC
|
Placebo Comparator: Placebo SC (Part A)
Single dose of placebo matching LY3113593 administered SC
|
Administered SC
Administered IV
|
Experimental: LY3113593 IV (Part B)
Single dose of LY3113593 administered IV
|
Administered IV
Administered SC
|
Placebo Comparator: Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV
|
Administered SC
Administered IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through end of study (Day 85)
|
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively.
A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason.
A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
|
Baseline through end of study (Day 85)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593
Time Frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593
Time Frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios
Time Frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
|
Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593
Time Frame: Baseline, Day 85
|
Baseline, Day 85
|
Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593
Time Frame: Baseline, Day 85
|
Baseline, Day 85
|
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
Time Frame: Baseline, Day 85
|
Baseline, Day 85
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15200
- I7C-MC-FEAA (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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