A Study of LY3127760 in Healthy Participants | NCT01968070 | Trialant
NCT01968070
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 7, 2019Actual
Enrollment
80Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
LY3127760
Celecoxib
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
NCT01968070
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15181
Secondary IDs
ID
Type
Description
Link
I7A-MC-EACA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3127760 in Healthy Participants
Official Title
A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2019
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
Oct 2013
Primary Completion Date
Apr 2014Actual
Completion Date
Apr 2014Actual
First Submitted Date
Oct 18, 2013
First Submission Date that Met QC Criteria
Oct 18, 2013
First Posted Date
Oct 23, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Mar 1, 2019
Results First Posted Date
Jun 7, 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
Mar 1, 2019
Last Update Posted Date
Jun 7, 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 main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.
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
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LY3127760 (Single)
Experimental
Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.
Drug: LY3127760
Drug: Placebo
Placebo (Single)
Placebo Comparator
Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.
Drug: LY3127760
Drug: Placebo
LY3127760 (Multiple)
Experimental
Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.
Drug: LY3127760
Drug: Placebo
Placebo (Multiple)
Placebo Comparator
Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.
Drug: LY3127760
Drug: Placebo
Celecoxib (Multiple)
Active Comparator
Multiple oral doses of 400 mg celecoxib administered QD for 28 days.
Drug: LY3127760
Drug: Celecoxib
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY3127760
Drug
Administered orally
Celecoxib (Multiple)
LY3127760 (Multiple)
LY3127760 (Single)
Placebo (Multiple)
Placebo (Single)
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
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Baseline to Study Completion (Up To Day 42)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Overtly healthy males or females as determined by medical history and physical examination
Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
Female participants not of child-bearing potential
Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m^2) inclusive
Are normotensive (defined as supine systolic blood pressure [BP] less than 140 millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg) without use of any antihypertensives
Exclusion Criteria:
Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea
Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis
Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission
Part 2 and Part 3 only
Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
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)
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.
Jin Y, Smith C, Hu L, Coutant DE, Whitehurst K, Phipps K, McNearney TA, Yang X, Ackermann B, Pottanat T, Landschulz W. LY3127760, a Selective Prostaglandin E4 (EP4) Receptor Antagonist, and Celecoxib: A Comparison of Pharmacological Profiles. Clin Transl Sci. 2018 Jan;11(1):46-53. doi: 10.1111/cts.12497. Epub 2017 Aug 30.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Part 1 was a single-ascending dose, 2-cohort, 3-period, alternating-group dose-escalation study (cohorts 1-2) and Part 2 of the study was a multiple-ascending dose, 4-cohort, parallel-group, dose-escalation study (cohorts 3-6). Replacement participants received interventions intended for those participants whom discontinued early.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 Sequence 1
Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;
FG001
Cohort 1 Sequence 2
Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;
FG002
Cohort 1 Sequence 3
Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;
FG003
Cohort 2 Sequence 1
Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
FG004
Cohort 2 Sequence 2
Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;
FG005
Cohort 2 Sequence 3
Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
FG006
Cohort 3 LY3127760 60mg
Participants received 60mg LY3127760 capsules orally once daily.
FG007
Cohort 3 Placebo
Participants received placebo capsules orally once daily.
FG008
Cohort 3 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
FG009
Cohort 4 LY3127760 200mg
Participants received 200mg LY3127760 capsules orally once daily.
FG010
Cohort 4 Placebo
Participants received placebo capsules orally once daily.
FG011
Cohort 4 Celcoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
FG012
Cohort 5 LY3127760 20mg
Participants received 20mg LY3127760 capsules orally once daily.
FG013
Cohort 5 Placebo
Participants received placebo capsules orally once daily.
FG014
Cohort 5 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
FG015
Cohort 6 LY3127760 600mg
Participants received 300mg LY3127760 capsules orally twice daily.
FG016
Cohort 6 Placebo
Participants received placebo capsules orally once daily.
FG017
Cohort 6 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG00610 subjects
FG0072 subjects
FG0082 subjects
FG0099 subjects
FG0102 subjects
FG0112 subjects
FG0129 subjects
FG0132 subjects
FG0142 subjects
FG0159 subjects
FG0162 subjects
FG0172 subjects
COMPLETED
FG0004 subjects
FG0013 subjects
FG0024 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects1 participant was added to replace the participant who discontinued the period 1.
FG0024 subjects
FG003
Period 3
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 Sequence 1
Participants received either placebo or 20 milligram (mg) or 200mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: 200mg LY3127760; Period 3: Placebo;
BG001
Cohort 1 Sequence 2
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, Categorical
Count of Participants
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
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
All randomized participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
No
Baseline to Study Completion (Up To Day 42)
ID
Title
Description
OG000
Part 1: Placebo
Placebo, Single Dose Administered PO
OG001
Part 1: 20 mg LY3127760
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Two participants were randomized into a Part 1 scheme where they received placebo 2 out of the 3 dosing periods. Those participants are represented only once in the placebo arm in adverse events.
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 1)
Placebo, Single Dose Administered PO
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA 16.0
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
C000630844
LY3127760
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
Sequential 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
Celecoxib
Drug
Administered orally
Celecoxib (Multiple)
Placebo
Drug
Administered orally
Celecoxib (Multiple)
LY3127760 (Multiple)
LY3127760 (Single)
Placebo (Multiple)
Placebo (Single)
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760
AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.
Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours
PK: Cmax of Multiple Doses LY3127760
Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours
PK: Tmax of Multiple Doses LY3127760
Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours
United States
3 subjects
FG0054 subjects
FG0068 subjects
FG0072 subjects
FG0082 subjects
FG0099 subjects
FG0102 subjects
FG0111 subjects
FG0129 subjects
FG0132 subjects
FG0142 subjects
FG0158 subjects
FG0162 subjects
FG0172 subjects
1 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
4 subjects
2 participants were added to replace the 2 participants who discontinued the period 1.
FG0043 subjects
FG0054 subjects
FG0060 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0070 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0080 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0090 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0100 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0110 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0120 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0130 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0140 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0150 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0160 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
FG0170 subjectsPart 2 (Cohorts 3 to 6) was planned only for one period.
COMPLETED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0042 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
4 subjects
FG0043 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Participants received either placebo or 20 milligram (mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 20mg LY3127760; Period 2: Placebo; Period 3: 900mg LY3127760;
BG002
Cohort 1 Sequence 3
Participants received either placebo or 200 milligram(mg) or 900mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 200 mg LY3127760; Period 3: 900 mg LY3127760;
BG003
Cohort 2 Sequence 1
Participants received either 60mg or 600mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
BG004
Cohort 2 Sequence 2
Participants received either placebo or 60 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: 60 mg LY3127760; Period 2: Placebo; Period 3: Placebo;
BG005
Cohort 2 Sequence 3
Participants received either Placebo or 600 mg LY3127760 capsules orally as per the below dosing sequence.
Period 1: Placebo; Period 2: 600 mg LY3127760; Period 3: 600 mg LY3127760 in fasting state;
BG006
Cohort 3 LY3127760 60mg
Participants received 60mg LY3127760 capsules orally once daily.
BG007
Cohort 3 Placebo
Participants received placebo capsules orally once daily.
BG008
Cohort 3 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
BG009
Cohort 4 LY3127760 200mg
Participants received 200mg LY3127760 capsules orally once daily.
BG010
Cohort 4 Placebo
Participants received placebo capsules orally once daily.
BG011
Cohort 4 Celcoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
BG012
Cohort 5 LY3127760 20mg
Participants received 20mg LY3127760 capsules orally once daily.
BG013
Cohort 5 Placebo
Participants received placebo capsules orally once daily.
BG014
Cohort 5 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
BG015
Cohort 6 LY3127760 300mg
Participants received 300mg LY3127760 capsules orally twice daily.
BG016
Cohort 6 Placebo
Participants received placebo capsules orally once daily.
BG017
Cohort 6 Celecoxib 400mg
Participants received 400mg Celecoxib capsules orally once daily.
BG018
Total
Total of all reporting groups
4
BG0015
BG0024
BG0036
BG0044
BG0054
BG00610
BG0072
BG0082
BG0099
BG0102
BG0112
BG0129
BG0132
BG0142
BG0159
BG0162
BG0172
BG01880
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
Between 18 and 65 years
BG0004
BG0015
BG0024
BG0036
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG0022
BG0032
BG0042
BG0050
BG0064
BG0071
BG0080
BG0091
BG0100
BG0112
BG0120
BG0131
BG0140
BG0151
BG0161
BG0170
BG01822
Male
BG0001
BG0013
BG0022
BG0034
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
Not Hispanic or Latino
BG0004
BG0015
BG0024
BG0036
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0021
BG0030
BG0041
BG0051
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0121
BG0130
BG0140
BG0150
BG0160
BG0170
BG0185
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0010
BG0022
BG0030
BG004
White
BG0003
BG0015
BG0021
BG0036
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0015
BG0024
BG0036
BG0044
BG0054
BG00610
BG0072
BG0082
BG0099
BG0102
BG0112
BG0129
BG0132
BG0142
BG0159
BG0162
BG0172
BG01880
20 mg LY3127760 Single Dose Administered PO
OG002
Part 1: 60 mg LY3127760
60 mg LY3127760 Single Dose Administered PO
OG003
Part 1: 200 mg LY3127760
200 mg LY3127760 Single Dose Administered PO
OG004
Part 1: 600 mg LY3127760
600 mg LY3127760 Single Dose Administered PO
OG005
Part 1: 600 mg LY3127760 (Fasted)
600 mg LY3127760 Single Dose Administered PO During Fasted State
OG006
Part 1: 900 mg LY3127760
900 mg LY3127760 Single Dose Administered PO
OG007
Part 2: Placebo
Placebo administered PO, once a day (QD), for 28 days.
OG008
Part 2: 20 mg LY3127760
20 mg LY3127760 administered PO, QD, for 28 days.
OG009
Part 2: 60 mg LY3127760
60 mg LY3127760 administered PO, QD, for 28 days.
OG010
Part 2: 200 mg LY3127760
200 mg LY3127760 administered PO, QD, for 28 days.