A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis

NCT ID: NCT02144285

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

LY3113593 IV (Part A)

Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels

Group Type: EXPERIMENTAL

LY3113593

Intervention Type: DRUG

Administered IV

Placebo IV (Part A)

Single dose of placebo matching LY3113593 administered IV

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV

LY3113593 SC (Part A)

Single dose of LY3113593 administered subcutaneous (SC)

Group Type: EXPERIMENTAL

LY3113593

Intervention Type: DRUG

Administered SC

Placebo SC (Part A)

Single dose of placebo matching LY3113593 administered SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

LY3113593 IV (Part B)

Single dose of LY3113593 administered IV

Group Type: EXPERIMENTAL

LY3113593

Intervention Type: DRUG

Administered IV

Placebo IV (Part B)

Single dose of placebo matching LY3113593 administered IV

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered IV

Interventions

LY3113593

Administered IV

Intervention Type: DRUG

LY3113593

Administered SC

Intervention Type: DRUG

Placebo

Administered IV

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Parexel Early Phase Unit at Glendale

Glendale, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Davita Clinical Research

Minneapolis, Minnesota, United States

Countries

United States

References

Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4.

Reference Type: DERIVED

PMID: 30677788 (View on PubMed)

Other Identifiers

I7C-MC-FEAA

Identifier Type: OTHER

Identifier Source: secondary_id

15200

Identifier Type: -

Identifier Source: org_study_id