A Study of LY3113593 in Healthy Participants and Particip... | NCT02144285 | Trialant
NCT02144285
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jan 22, 2019Actual
Enrollment
64Actual
Phase
Phase 1
Conditions
Kidney Failure, Chronic
Interventions
LY3113593
LY3113593
Placebo
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02144285
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15200
Secondary IDs
ID
Type
Description
Link
I7C-MC-FEAA
Other Identifier
Eli Lilly and Company
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
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2014
Primary Completion Date
Aug 2015Actual
Completion Date
Aug 2015Actual
First Submitted Date
May 19, 2014
First Submission Date that Met QC Criteria
May 19, 2014
First Posted Date
May 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 21, 2017
Results First Submitted that Met QC Criteria
Aug 3, 2018
Results First Posted Date
Jan 22, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 3, 2018
Last Update Posted Date
Jan 22, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Kidney Failure, Chronic
Keywords
Renal dialysis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
64Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3113593
Drug
Administered IV
LY3113593 IV (Part A)
LY3113593 IV (Part B)
Outcomes Module
Primary Outcomes
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
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
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
FG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
FG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
FG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
FG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
FG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
FG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
FG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
FG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
FG009
LY IV 150mg(Part B)
Single dose of LY3113593 administered IV at 150 mg.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00014 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0082 subjects
FG0096 subjects
Received At Least One Dose of Study Drug
FG00014 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
COMPLETED
FG00014 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
BG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
All enrolled participants Age data as per Part in trial.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
All enrolled participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
No
Baseline through end of study (Day 85)
ID
Title
Description
OG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
All enrolled participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Blepharitis
Eye disorders
MedDRA 17.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D007676
Kidney Failure, Chronic
Ancestor Terms
ID
Term
D051436
Renal Insufficiency, Chronic
D051437
Renal Insufficiency
D007674
Kidney Diseases
D014570
Urologic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Placebo
LY3113593
Drug
Administered SC
LY3113593 SC (Part A)
Placebo
Drug
Administered IV
Placebo IV (Part A)
Placebo IV (Part B)
Placebo
Drug
Administered SC
Placebo SC (Part A)
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
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
Baseline, Day 85
Orlando
Florida
32809
United States
Davita Clinical Research
Minneapolis
Minnesota
55404
United States
FG004
6 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0082 subjects
FG0096 subjects
5 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0082 subjects
FG0096 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
BG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
BG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
BG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
BG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
BG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
BG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
BG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
BG009
LY IV 150mg (Part B)
Single dose of LY3113593 administered IV at 150 mg.
BG010
Total
Total of all reporting groups
14
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0076
BG0082
BG0096
BG01064
Mean
Standard Deviation
years
Title
Denominators
Categories
Part A
ParticipantsBG00014
ParticipantsBG0016
ParticipantsBG0026
ParticipantsBG0036
ParticipantsBG0046
ParticipantsBG0056
ParticipantsBG0066
ParticipantsBG0076
ParticipantsBG0080
ParticipantsBG0090
ParticipantsBG01056
Title
Measurements
BG00037.8± 10.69
BG00145.0± 7.40
BG00231.0± 5.22
BG003
Part B
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00014
ParticipantsBG0016
ParticipantsBG0026
ParticipantsBG0036
ParticipantsBG0046
ParticipantsBG0056
ParticipantsBG0066
ParticipantsBG0076
ParticipantsBG0082
ParticipantsBG0096
ParticipantsBG01064
Title
Measurements
Female
BG0001
BG0012
BG0020
BG003
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00014
ParticipantsBG0016
ParticipantsBG0026
ParticipantsBG0036
ParticipantsBG0046
ParticipantsBG0056
ParticipantsBG0066
ParticipantsBG0076
ParticipantsBG0082
ParticipantsBG0096
ParticipantsBG01064
Title
Measurements
Hispanic or Latino
BG0002
BG0014
BG0021
BG003
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00014
ParticipantsBG0016
ParticipantsBG0026
ParticipantsBG0036
ParticipantsBG0046
ParticipantsBG0056
ParticipantsBG0066
ParticipantsBG0076
ParticipantsBG0082
ParticipantsBG0096
ParticipantsBG01064
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG00014
ParticipantsBG0016
ParticipantsBG0026
ParticipantsBG0036
ParticipantsBG0046
ParticipantsBG0056
ParticipantsBG0066
ParticipantsBG0076
ParticipantsBG0082
ParticipantsBG0096
ParticipantsBG01064
Title
Measurements
BG00014
BG0016
BG0026
BG003
OG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
OG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG008
Placebo IV (Part B)
Single dose of LY3113593 administered IV.
OG009
LY IV 150mg (Part B)
Single dose of LY3113593 administered IV at 150 mg.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0082
OG0096
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593
All enrolled participants who received at least one dose of LY3113593 study drug.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
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
ID
Title
Description
OG000
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG001
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG002
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG003
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
OG004
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG005
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG006
LY SC 150 mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG007
LY IV 150 mg (Part B)
Single dose of LY3113593 administered IV at 150mg.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000559± 15
OG0012070± 14
OG0026330± 13
OG003
Secondary
Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593
All enrolled participants who received at least one dose of LY3113593 study drug.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hour per milliliter (ng*hr/mL)
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
ID
Title
Description
OG000
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG001
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG002
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG003
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
OG004
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG005
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG006
LY SC 150 mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG007
LY IV 150mg (Part B)
Single dose of LY3113593 administered IV at 150 mg.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00055700± 29
OG001280000± 14
OG0021100000± 9
OG003
Secondary
Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios
All enrolled participants who received at least one dose of 150mg LY3113593 study drug.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
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
ID
Title
Description
OG000
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG001
LY IV 150mg (Part A)
Single dose of LY3113593 (LY) administered IV at 150 mg.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0007640000± 37
OG00117000000± 28
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Absolute Bioavailability
0.45
2-Sided
90
0.34
0.60
Superiority or Other
Secondary
Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593
All enrolled participants who received at least one dose of study drug and had baseline and post baseline iron profile data.
Posted
Mean
Standard Deviation
micromoles per liter (μmol/L)
Baseline, Day 85
ID
Title
Description
OG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
OG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
OG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
OG009
LY IV (Part B)
Single dose of LY3113593 administered IV.
Units
Counts
Participants
OG00012
OG0016
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.78± 12.5
OG0014.12± 5.49
OG0029.46± 11.6
OG003
Secondary
Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593
All enrolled participants who received at least one dose of study drug and had baseline and post baseline Tsat profile data.
Posted
Mean
Standard Deviation
percentage of change
Baseline, Day 85
ID
Title
Description
OG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
OG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
OG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
OG009
LY IV (Part B)
Single dose of LY3113593 administered IV.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.00± 22.00
OG0016.80± 10.00
OG00214.80± 18.00
OG003
Secondary
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
All enrolled participants who received at least one dose of study drug and had baseline and post baseline Hb profile data.
Posted
Mean
Standard Deviation
millimoles per liter of iron (mml/L-Fe)
Baseline, Day 85
ID
Title
Description
OG000
Placebo (Part A)
Single dose of placebo matching LY3113593.
OG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
OG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
OG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
OG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg
OG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
OG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
OG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
OG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
OG009
LY IV (Part B)
Single dose of LY3113593 administered IV.
Units
Counts
Participants
OG00014
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.269± 0.455
OG0010.425± 0.363
OG0020.123± 0.486
OG003
0
14
4
14
EG001
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
0
6
3
6
EG002
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
0
6
2
6
EG003
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
0
6
2
6
EG004
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
0
6
5
6
EG005
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
0
6
3
6
EG006
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
0
6
2
6
EG007
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
0
6
2
6
EG008
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
0
2
0
2
EG009
LY IV (Part B)
Single dose of LY3113593 administered IV.
1
6
3
6
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 affected2 at risk
EG0091 events1 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected6 at risk
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Ulcerative keratitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Toothache
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Influenza like illness
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected6 at risk
Infusion site pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Food allergy
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Seasonal allergy
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Conjunctivitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Rhinitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0043 events3 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected6 at risk
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0092 events2 affected6 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Electrocardiogram abnormal
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Weight decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Dysgeusia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected14 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected2 at risk
EG0090 events0 affected6 at risk
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications