Healthy VolunteersPhase 1NCT01632566

A Multiple-dose Study of LY3031207 in Healthy Participants

A Phase 1 study testing LY3031207, Celecoxib and Simvastatin in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY3031207, Celecoxib and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Apr 2013
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Overtly healthy individuals based on the history and physical examinations as determined by the investigator, including first generation Japanese
Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

Who cannot join

Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA [HMG CoA] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded

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.
Honolulu, Hawaii

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About this study

Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects

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 healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.

Conditions: Healthy Volunteers
Being tested: Placebo, LY3031207, Celecoxib, Simvastatin

What participants receive

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

PlaceboDrug
Capsules administered orally
LY3031207Drug
Administered orally
CelecoxibDrug
Administered orally
SimvastatinDrug
Administered orally

Study groups in NCT01632566
Study group	Role	What they receive
Placebo	Placebo comparator	Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage. Receives: Drug: Placebo
LY3031207	Experimental	Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days. Receives: Drug: LY3031207
Celecoxib	Active comparator	Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207. Receives: Drug: Celecoxib
LY3031207 + Simvastatin	Other	Daily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207. Receives: Drug: Simvastatin

What is being measured

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

Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities.
A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)

Secondary outcomes (9)

Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Measured: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
Area under the concentration versus time curve in a dosing interval (AUC[0-tau]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Measured: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.
Measured: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
Measured: Predose up to 48 hours post dose at Day -3 and Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
Area under the concentration versus time curve over the range of all measureable concentrations (AUC[0-tlast]) of simvastatin.
Measured: Predose up to 48 hours post dose at Day -3 and Day 28
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
Measured: Predose up to 48 hours post dose at Day -3 and Day 28
Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion
Measured: Baseline, Predose up to 12 hours prior to last dose at Day 28
Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion
Measured: Baseline, Predose up to time of last dose at Day 28
Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion
Measured: Baseline, Predose up to 12 hours prior to last dose at Day 28

Timeline

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

Jun 2012Apr 2013

First posted3 Jul 2012 (estimated)
Study startJun 2012
Primary completionApr 2013
Study completionApr 2013

Why it stopped: Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.

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.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01632566
Sponsor's protocol ID: 14284
Other IDs: I5W-EW-LBCB
Status last verified: Mar 2019
First submitted: 25 Jun 2012
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects
ClinicalTrials.gov ID: NCT01632566
Acronym / sponsor ID: 14284
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.
Enrolment: 39 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 3 Jul 2012 (estimated)
Results: Posted 27 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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboDaily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.
LY3031207	Experimental	Drug: LY3031207Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.
Celecoxib	Active comparator	Drug: CelecoxibDaily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.
LY3031207 + Simvastatin	Other	Drug: SimvastatinDaily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Overtly healthy individuals based on the history and physical examinations as determined by the investigator, including first generation Japanese
Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

Key exclusion criteria (1 listed)

Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA [HMG CoA] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded

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
PlaceboCapsules administered orally	Drug	Placebo
LY3031207Administered orally	Drug	LY3031207
CelecoxibAdministered orally	Drug	Celecoxib
SimvastatinAdministered orally	Drug	LY3031207 + Simvastatin

Primary outcome

Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

9 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
Time frame: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
Time frame: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
Time frame: Predose up to 48 hours post last dose at Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
Time frame: Predose up to 48 hours post dose at Day -3 and Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
Time frame: Predose up to 48 hours post dose at Day -3 and Day 28
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
Time frame: Predose up to 48 hours post dose at Day -3 and Day 28
Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion
Time frame: Baseline, Predose up to 12 hours prior to last dose at Day 28
Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion
Time frame: Baseline, Predose up to time of last dose at Day 28
Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion
Time frame: Baseline, Predose up to 12 hours prior to last dose at Day 28

Results and safety

Results posted to the registry on 27 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
25 mg LY3031207	8	8
75 mg LY3031207 and Simvastatin	10	7
225 mg LY3031207 and Simvastatin	9	0
Placebo With or Without Simvastatin	6	4
400 mg Celecoxib With or Without Simvastatin	6	4

Primary outcome: Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs

Time frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks). Count of participants. Unit: Participants

Measure	25 mg LY3031207 n = 8	75 mg LY3031207 and Simvastatin n = 10	225 mg LY3031207 and Simvastatin n = 9	Placebo With or Without Simvastatin n = 6	400 mg Celecoxib With or Without Simvastatin n = 6	10 mg Simvastatin n = 27
Participants with one or more AEs	3	5	9	1	1	3
Participants with one or more serious AEs	0	0	2	0	0	0

Population analysed: Participants who received at least one dose of study drug.

9 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 With or Without Simvastatin	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
25 mg LY3031207	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
75 mg LY3031207 and Simvastatin	0 of 10 (0%)	5 of 10 (50%)	Not reported
225 mg LY3031207 and Simvastatin	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
400 mg Celecoxib With or Without Simvastatin	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
10 mg Simvastatin	0 of 27 (0%)	3 of 27 (11.1%)	Not reported

Limitations and caveats (from the sponsor): Lilly voluntarily discontinued dosing of LY3031207 for all participants in LBCB because of early discontinuation criteria being met. Data for some endpoints (including blood pressure and Japanese comparison) were incomplete for the planned analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 LY3031207, Celecoxib and Simvastatin 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 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 27 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 Drug Related Adverse Events (AEs) or Any Serious AEs (time frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)). 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 NCT01632566.

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 27 Jun 2019.