A Single Dose Study of LY3023703 in Healthy Participants | NCT01632579 | Trialant
NCT01632579
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Aug 6, 2018Actual
Enrollment
30Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
LY3023703
Placebo
Celecoxib
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
NCT01632579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14707
Secondary IDs
ID
Type
Description
Link
I6H-MC-MCBA
Other Identifier
Eli Lilly and Company
Brief Title
A Single Dose Study of LY3023703 in Healthy Participants
Official Title
A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3023703 in Healthy Subjects
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jul 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 2012
Primary Completion Date
Sep 2012Actual
Completion Date
Sep 2012Actual
First Submitted Date
Jun 25, 2012
First Submission Date that Met QC Criteria
Jun 28, 2012
First Posted Date
Jul 3, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Jul 30, 2018
Results First Posted Date
Aug 6, 2018Actual
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
Jul 30, 2018
Last Update Posted Date
Aug 6, 2018Actual
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
This is a phase I study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Volunteers
Keywords
Not provided
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
30Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Single dose of placebo administered orally on up to one occasion separated by at least a 3 week wash out period.
Drug: Placebo
LY3023703
Experimental
Up to 6 single escalating doses of LY3023703 [0.1 milligram (mg) up to 60 mg] administered orally on up to two occasions per participant separated by at least a 3 week wash out period.
Drug: LY3023703
400 mg Celecoxib
Active Comparator
Positive control. Single 400 mg dose of celecoxib administered orally, open label, on one occasion separated by at least a 3 week washout period.
Drug: Celecoxib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3023703
Drug
Administered orally
LY3023703
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
Baseline up to Day 7 post-dose
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703
Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703
Area under the concentration time curve from the time of dosing to the time of the last observation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Overtly healthy individuals based on the history and physical examinations as determined by the investigator
Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m^2), inclusive
Exclusion Criteria:
Have known allergies to LY3023703 or any components of the formulation, celecoxib, or sulfonamides. Participants with known aspirin allergy, allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs), or allergies or intolerance to other selective microsomal prostaglandin E synthase (mPGES-1) inhibitors should also be excluded
Have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea, or positive Helicobacter pylori serology
Use NSAIDs, celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day) within 14 days of screening
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
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)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Evansville
Indiana
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
The study had 3 periods. Period 1: 0.1 milligram (mg), 0.5 mg, 2.5 mg LY3023703 or placebo. Period 2: 10 mg, 30 mg, 60 mg LY3023703 or placebo. Period 3: 400 mg celecoxib. There was at least a 3-week washout between periods and at least 7 days between dosing of each cohort in Periods 1 and 2.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 Sequence 1
Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 0.1 mg LY3023703 in week 1, Period 2: Placebo in week 4 and Period 3: 400mg celecoxib in week 8.
FG001
Cohort 1 Sequence 2
Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 0.1 mg LY3023703 in week 1, Period 2: 10 mg LY3023703 in week 4 and Period 3: 400mg celecoxib in week 7.
FG002
Cohort 1 Sequence 3
Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: Placebo in week 1, Period 2: 10 mg LY3023703 in week 4 and Period 3: 400mg celecoxib in week 7.
FG003
Cohort 2 Sequence 1
Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 0.5 mg LY3023703 in week 2, Period 2: Placebo in week 5 and Period 3: 400mg celecoxib in week 8.
FG004
Cohort 2 Sequence 2
Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 0.5 mg LY3023703 in week 2, Period 2: 30 mg LY3023703 in week 5 and Period 3: 400mg celecoxib in week 8.
FG005
Cohort 2 Sequence 3
Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: Placebo in week 2, Period 2: 30 mg LY3023703 in week 5 and Period 3: 400mg celecoxib in week 8.
FG006
Cohort 3 Sequence 1
Participants received LY3023703, placebo and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 2.5 mg LY3023703 in week 3, Period 2: Placebo in week 6 and Period 3: 400mg celecoxib in week 9.
FG007
Cohort 3 Sequence 2
Participants received LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: 2.5 mg LY3023703 in week 3, Period 2: 60 mg LY3023703 in week 6 and Period 3: 400mg celecoxib in week 9.
FG008
Cohort 3 Sequence 3
Participants received placebo, LY3023703 and celecoxib capsules orally as per the below dosing sequence in each period.
Period 1: Placebo in week 3, Period 2: 60 mg LY3023703 in week 6 and Period 3: 400mg celecoxib in week 9.
Periods
Title
Milestones
Reasons Not Completed
Period 1 (First Intervention)
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG004
Received at Least 1 Dose
FG0002 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG004
COMPLETED
FG0002 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Washout Period
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0016 subjects
FG0022 subjects
FG003
Period 2 (Second Intervention)
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0016 subjects
FG0022 subjects
FG003
Washout Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG003
Period 3 (Third Intervention)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Entire Study Population
Depending on the cohort and period, participants received either an LY3023703 capsule (0.1-mg, 0.5-mg, 2.5-mg, 10-mg, 30-mg, or 60-mg strength) or placebo administered orally once in Periods 1 and 2. In Period 3, participants were administered 400 mg celecoxib, orally. Each dose of study drug was followed by a washout period of at least 3 weeks.
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
Mean
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 Drug Related Adverse Events (AEs) or Any Serious AE
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
Safety population: participants who received at least 1 dose of study drug or placebo, whether or not he/she completed all the protocol requirements.
Posted
Count of Participants
Participants
No
Baseline up to Day 7 post-dose
ID
Title
Description
OG000
Placebo
Matched placebo capsules administered orally in Periods 1 or 2.
OG001
0.1 mg LY3023703
Adverse Events Module
Frequency Threshold
3
Time Frame
Not provided
Description
Not provided
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
Matched placebo capsules administered orally in Periods 1 or 2.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lacrimation increased
Eye disorders
MedDRA 15.0
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
D000068579
Celecoxib
Ancestor Terms
ID
Term
D000096926
Benzenesulfonamides
D013449
Sulfonamides
D000577
Amides
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug
Administered orally
Placebo
Celecoxib
Drug
Administered orally
400 mg Celecoxib
Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose
Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
Percent change from baseline of PGE synthesis=(postdose PGE synthesis-baseline PGE synthesis)/baseline PGE synthesis*100, where the unit of measure for PGE synthesis is nanograms per milliliter (ng/ml).
Baseline, 0.5 hours (h), 1 h, 2 h, 8 h, 24 h, and 144 h post-dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
Urinary excretion of PGEM, after correcting for urinary creatinine. PGEM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGEM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, 6 to 12 h, and 12 to 24 hours post-dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
Urinary excretion of PGIM, after correcting for urinary creatinine. PGIM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGIM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
Urinary excretion of TXAM, after correcting for urinary creatinine. TXAM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of TXAM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose
United States
6 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
6 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
6 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
2 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
COMPLETED
FG0001 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
2 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
Received at Least 1 Dose
FG0001 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
COMPLETED
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
2 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
COMPLETED
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
2 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
Received at Least 1 Dose
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
COMPLETED
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0032 subjects
FG0046 subjects
FG0052 subjects
FG0062 subjects
FG0076 subjects
FG0082 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
30
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.0± 10.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
Male
BG00019
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
Not Hispanic or Latino
BG00029
Unknown or Not Reported
BG0000
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
Asian
BG0000
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG0003
White
BG00026
More than one race
BG0000
Unknown or Not Reported
BG0000
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00030
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG002
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG004
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG005
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG006
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
OG007
Celecoxib
400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
Units
Counts
Participants
OG00012
OG0018
OG0028
OG0038
OG0047
OG0058
OG0068
OG00728
Title
Denominators
Categories
Any Serious AE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Drug-Related AE
Title
Measurements
OG0003
OG0010
OG0020
OG003
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703
Pharmacokinetic (PK) population: participants who received at least 1 dose of study drug and had evaluable Cmax data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose
ID
Title
Description
OG000
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG001
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG002
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG004
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG005
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.15± 25.4
OG0015.66± 27.7
OG00223.5± 23.7
OG003
Secondary
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703
Area under the concentration time curve from the time of dosing to the time of the last observation.
Pharmacokinetic (PK) population: All participants who received at least 1 dose of study drug and had evaluable AUC data.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanograms per milliliter (hr*ng/mL)
Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose
ID
Title
Description
OG000
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG001
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG002
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG004
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG005
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.19± 52.0
OG00154.7± 72.4
OG002245± 58.5
OG003
Secondary
Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
Percent change from baseline of PGE synthesis=(postdose PGE synthesis-baseline PGE synthesis)/baseline PGE synthesis*100, where the unit of measure for PGE synthesis is nanograms per milliliter (ng/ml).
All participants who received at least 1 dose of study drug or placebo and had evaluable PGE data at the specific time points.
Posted
Median
Inter-Quartile Range
percent change in PGE
Baseline, 0.5 hours (h), 1 h, 2 h, 8 h, 24 h, and 144 h post-dose
ID
Title
Description
OG000
Placebo
Matched placebo capsules administered orally in Periods 1 or 2.
OG001
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG002
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG004
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG005
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG006
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
OG007
Celecoxib
400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
Units
Counts
Participants
OG00011
OG0011
OG0028
OG003
Title
Denominators
Categories
Percent Change at 0.5 h
ParticipantsOG00011
ParticipantsOG0011
ParticipantsOG0028
ParticipantsOG003
Secondary
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
Urinary excretion of PGEM, after correcting for urinary creatinine. PGEM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGEM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
All participants who received at least 1 dose of study drug or placebo and had evaluable PGEM data at specific time points.
Posted
Median
Inter-Quartile Range
percent change in PGEM
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, 6 to 12 h, and 12 to 24 hours post-dose
ID
Title
Description
OG000
Placebo
Matched placebo capsules administered orally in Periods 1 or 2.
OG001
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG002
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG004
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG005
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG006
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
OG007
Celecoxib
400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
Units
Counts
Participants
OG00012
OG0018
OG0028
OG003
Title
Denominators
Categories
Percent Change at 0 to 2 h
ParticipantsOG00012
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Secondary
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
Urinary excretion of PGIM, after correcting for urinary creatinine. PGIM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGIM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
All participants who received at least 1 dose of study drug or placebo and had evaluable PGIM data at specific time points.
Posted
Median
Inter-Quartile Range
percent change in PGIM
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose
ID
Title
Description
OG000
Placebo
Matched placebo capsules administered orally in Periods 1 or 2.
OG001
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG002
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG004
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG005
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG006
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
OG007
Celecoxib
400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
Units
Counts
Participants
OG00012
OG0018
OG0028
OG003
Title
Denominators
Categories
Percent Change at 0 to 2 h
ParticipantsOG00012
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Secondary
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
Urinary excretion of TXAM, after correcting for urinary creatinine. TXAM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of TXAM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.
All participants who received at least 1 dose of study drug or placebo and had evaluable TXAM data at specific time points.
Posted
Median
Inter-Quartile Range
percent change in TXAM
Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose
ID
Title
Description
OG000
Placebo
Matched placebo capsules administered orally in Periods 1 or 2.
OG001
0.1 mg LY3023703
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
OG002
0.5 mg LY3023703
0.5-mg LY3023703 capsule administered orally, once in Period 1.
OG003
2.5 mg LY3023703
2.5-mg LY3023703 capsule administered orally, once in Period 1.
OG004
10 mg LY3023703
10-mg LY3023703 capsule administered orally, once in Period 2.
OG005
30 mg LY3023703
30-mg LY3023703 capsule administered orally, once in Period 2.
OG006
60 mg LY3023703
60-mg LY3023703 capsule administered orally, once in Period 2.
OG007
Celecoxib
400-mg celecoxib dose (two 200-mg celecoxib capsules) administered orally, once in Period 3.
Units
Counts
Participants
OG00012
OG0018
OG0028
OG003
Title
Denominators
Categories
Percent Change at 0 to 2 h
ParticipantsOG00012
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
0
12
3
12
EG001
LY3023703 0.1 mg
0.1-milligram (mg) LY3023703 capsule administered orally, once in Period 1.
0
8
1
8
EG002
LY3023703 0.5 mg
0.5-mg LY3023703 capsule administered orally, once in Period 1.
0
8
0
8
EG003
LY3023703 2.5 mg
2.5-mg LY3023703 capsule administered orally, once in Period 1.
0
8
2
8
EG004
LY3023703 10 mg
10-mg LY3023703 capsule administered orally, once in Period 2.
0
7
0
7
EG005
LY3023703 30 mg
30-mg LY3023703 capsule administered orally, once in Period 2.
0
8
4
8
EG006
LY3023703 60 mg
60-mg LY3023703 capsule administered orally, once in Period 2.
0
8
2
8
EG007
Celecoxib
400-mg celecoxib capsule, administered orally, once in Period 3.