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

NCT02144285 | Completed Phase 1 Results

• 2 other identifiers: 15200I7C-MC-FEAA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

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

Keywords

Renal dialysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  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 Outcomes (6)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593

  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

  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

  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

  Baseline, Day 85

• Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593

  Baseline, Day 85

Study Arms (6)

LY3113593 IV (Part A)

EXPERIMENTAL

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

Drug: LY3113593

Placebo IV (Part A)

PLACEBO COMPARATOR

Single dose of placebo matching LY3113593 administered IV

Drug: Placebo

LY3113593 SC (Part A)

EXPERIMENTAL

Single dose of LY3113593 administered subcutaneous (SC)

Drug: LY3113593

Placebo SC (Part A)

PLACEBO COMPARATOR

Single dose of placebo matching LY3113593 administered SC

Drug: Placebo

LY3113593 IV (Part B)

EXPERIMENTAL

Single dose of LY3113593 administered IV

Drug: LY3113593

Placebo IV (Part B)

PLACEBO COMPARATOR

Single dose of placebo matching LY3113593 administered IV

Drug: Placebo

Interventions

LY3113593 DRUG

Administered IV

LY3113593 IV (Part A); LY3113593 IV (Part B)

Placebo DRUG

Administered IV

Placebo IV (Part A); Placebo IV (Part B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

• 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.

  PMID: 30677788 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08

Locations

US (3)