Healthy VolunteersPhase 1NCT01968070

A Study of LY3127760 in Healthy Participants

A Phase 1 study testing LY3127760 and Celecoxib in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY3127760 and Celecoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Apr 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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, 47710

Other trials in United States

About this study

Official title: A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects

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.

Conditions: Healthy Volunteers
Being tested: LY3127760, Celecoxib, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3127760Drug
Administered orally
CelecoxibDrug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT01968070
Study group	Role	What they receive
LY3127760 (Single)	Experimental	Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: LY3127760; Drug: Placebo
Celecoxib (Multiple)	Active comparator	Multiple oral doses of 400 mg celecoxib administered QD for 28 days. Receives: Drug: LY3127760; Drug: Celecoxib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Study Completion (Up To Day 42)

Secondary outcomes (6)

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours
PK: Cmax of Multiple Doses LY3127760
Measured: 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
Measured: Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Apr 2014

First posted23 Oct 2013 (estimated)
Study startOct 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01968070
Sponsor's protocol ID: 15181
Other IDs: I7A-MC-EACA
Status last verified: Mar 2019
First submitted: 18 Oct 2013
Last updated: 7 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28857461

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects
ClinicalTrials.gov ID: NCT01968070
Acronym / sponsor ID: 15181
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 23 Oct 2013 (estimated)
Results: Posted 7 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY3127760 (Single)	Experimental	Drug: LY3127760, Drug: PlaceboSingle oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.
Placebo (Single)	Placebo comparator	Drug: LY3127760, Drug: PlaceboSingle oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.
LY3127760 (Multiple)	Experimental	Drug: LY3127760, Drug: PlaceboMultiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.
Placebo (Multiple)	Placebo comparator	Drug: LY3127760, Drug: PlaceboMultiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.
Celecoxib (Multiple)	Active comparator	Drug: LY3127760, Drug: Celecoxib, Drug: PlaceboMultiple oral doses of 400 mg celecoxib administered QD for 28 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3127760Administered orally	Drug	Celecoxib (Multiple), LY3127760 (Multiple), LY3127760 (Single), Placebo (Multiple), Placebo (Single)
CelecoxibAdministered orally	Drug	Celecoxib (Multiple)
PlaceboAdministered orally	Drug	Celecoxib (Multiple), LY3127760 (Multiple), LY3127760 (Single), Placebo (Multiple), Placebo (Single)

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to Study Completion (Up To Day 42)
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.

6 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours
PK: Cmax of Multiple Doses LY3127760
Time frame: 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
Time frame: Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours

Results and safety

Results posted to the registry on 7 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Sequence 1	4	4
Cohort 1 Sequence 2	4	3
Cohort 1 Sequence 3	4	4
Cohort 2 Sequence 1	4	2
Cohort 2 Sequence 2	4	3
Cohort 2 Sequence 3	4	4
Cohort 3 LY3127760 60mg	10	8
Cohort 3 Placebo	2	2
Cohort 3 Celecoxib 400mg	2	2
Cohort 4 LY3127760 200mg	9	9
Cohort 4 Placebo	2	2
Cohort 4 Celcoxib 400mg	2	1
Cohort 5 LY3127760 20mg	9	9
Cohort 5 Placebo	2	2
Cohort 5 Celecoxib 400mg	2	2
Cohort 6 LY3127760 600mg	9	8
Cohort 6 Placebo	2	2
Cohort 6 Celecoxib 400mg	2	2

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

Time frame: Baseline to Study Completion (Up To Day 42). Count of participants. Unit: Participants

Measure	Part 1: Placebo n = 19	Part 1: 20 mg LY3127760 n = 8	Part 1: 60 mg LY3127760 n = 8	Part 1: 200 mg LY3127760 n = 8	Part 1: 600 mg LY3127760 n = 8	Part 1: 600 mg LY3127760 (Fasted) n = 8	Part 1: 900 mg LY3127760 n = 8	Part 2: Placebo n = 8	Part 2: 20 mg LY3127760 n = 9	Part 2: 60 mg LY3127760 n = 10	Part 2: 200 mg LY3127760 n = 9	Part 2: 300 mg LY3127760 n = 9	Part 2: 400 mg Celecoxib n = 8
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least one dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part 1)	0 of 19 (0%)	4 of 19 (21.1%)	Not reported
20 mg LY3127760 (Part 1)	0 of 8 (0%)	2 of 8 (25%)	Not reported
60 mg LY3127760 (Part 1)	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
200 mg LY3127760 (Part 1)	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
600 mg LY3127760 (Part 1)	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
600 mg LY3127760 (Fasted) (Part 1)	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
900 mg LY3127760 (Part 1)	0 of 8 (0%)	2 of 8 (25%)	Not reported
Placebo (Part 2)	0 of 8 (0%)	2 of 8 (25%)	Not reported
20 mg LY3127760 (Part 2)	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
60 mg LY3127760 (Part 2)	0 of 10 (0%)	5 of 10 (50%)	Not reported
200 mg LY3127760 (Part 2)	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
300 mg LY3127760 (Part 2)	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
400 mg Celecoxib (Part 2)	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28857461Jin 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3127760 and Celecoxib in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Study Completion (Up To Day 42)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01968070, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.