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

Primary Purpose

Kidney Failure, Chronic

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3113593

Placebo

About this trial

This is an interventional other trial for Kidney Failure, Chronic focused on measuring Renal dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Parexel Early Phase Unit at Glendale
Orlando Clinical Research Center
Davita Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3113593 IV (Part A)

Placebo IV (Part A)

LY3113593 SC (Part A)

Placebo SC (Part A)

LY3113593 IV (Part B)

Placebo IV (Part B)

Arm Description

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

Single dose of placebo matching LY3113593 administered IV

Single dose of LY3113593 administered subcutaneous (SC)

Single dose of placebo matching LY3113593 administered SC

Single dose of LY3113593 administered IV

Single dose of placebo matching LY3113593 administered IV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593

Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593

Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios

Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593

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

Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593

Full Information

NCT ID

NCT02144285

First Posted

May 19, 2014

Last Updated

August 3, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02144285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

Keywords

Renal dialysis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3113593 IV (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo IV (Part A)

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo matching LY3113593 administered IV

Arm Title

LY3113593 SC (Part A)

Arm Type

Experimental

Arm Description

Single dose of LY3113593 administered subcutaneous (SC)

Arm Title

Placebo SC (Part A)

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo matching LY3113593 administered SC

Arm Title

LY3113593 IV (Part B)

Arm Type

Experimental

Arm Description

Single dose of LY3113593 administered IV

Arm Title

Placebo IV (Part B)

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo matching LY3113593 administered IV

Intervention Type

Drug

Intervention Name(s)

LY3113593

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

LY3113593

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline through end of study (Day 85)

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593

Time Frame

Baseline, Day 85

Title

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

Time Frame

Baseline, Day 85

Title

Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593

Time Frame

Baseline, Day 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Parexel Early Phase Unit at Glendale

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Davita Clinical Research

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30677788

Citation

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.

Results Reference

derived

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

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