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TerminatedNCT01632566Updated Jun 27, 2019Results posted

A Multiple-dose Study of LY3031207 in Healthy Participants

A Phase 1 interventional study of Placebo and LY3031207 in Healthy Volunteers, sponsored by Eli Lilly and Company. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Why this study was terminated
Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.
Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
39 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.

    Drug: Placebo

  • Experimental
    LY3031207

    Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.

    Drug: LY3031207

  • Active comparator
    Celecoxib

    Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.

    Drug: Celecoxib

  • Other
    LY3031207 + Simvastatin

    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.

    Drug: Simvastatin

Interventions

  • DrugPlacebo

    Capsules administered orally

  • DrugLY3031207

    Administered orally

  • DrugCelecoxib

    Administered orally

  • DrugSimvastatin

    Administered orally

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks)

Secondary outcomes

  1. 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.

    Time frame: Predose up to 48 hours post last dose at Day 28

  2. 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.

    Time frame: Predose up to 48 hours post last dose at Day 28

  3. 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.

    Time frame: Predose up to 48 hours post last dose at Day 28

  4. Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin

    Time frame: Predose up to 48 hours post dose at Day -3 and Day 28

  5. 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.

    Time frame: Predose up to 48 hours post dose at Day -3 and Day 28

  6. Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin

    Time frame: Predose up to 48 hours post dose at Day -3 and Day 28

  7. 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

  8. 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

  9. 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

07

Results

Posted Jun 27, 2019
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
Milestone25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without Simvastatin
Started810966
Received at least one dose ly3031207810900
Received at least one dose simvastatin010944
Completed87044
Not completed03922
Withdrew: Withdrawal by subject01000
Withdrew: Sponsor decision02922

Outcome measures

PrimaryNumber 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.

Time frame:
Baseline to study completion (treatment completion and follow-up, up to 35 weeks)
Reported as:
Count of participants · Participants
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Participants25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without Simvastatin10 mg Simvastatin
Participants with one or more AEs359113
Participants with one or more serious AEs002000
SecondaryPharmacokinetics: 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.

Time frame:
Predose up to 48 hours post last dose at Day 28
Reported as:
Geometric mean · nanograms/milliliter (ng/mL)
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
nanograms/milliliter (ng/mL)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and Simvastatin
Pharmacokinetics: Maximum Concentration (Cmax) of LY30312071120 ± 34.32290 ± 42.4—
SecondaryPharmacokinetics: 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.

Time frame:
Predose up to 48 hours post last dose at Day 28
Reported as:
Geometric mean · nanograms*hours/milliliter (hr*ng/mL)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207
nanograms*hours/milliliter (hr*ng/mL)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and Simvastatin
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY303120712000 ± 39.730400 ± 45.0—
SecondaryPharmacokinetics: 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.

Time frame:
Predose up to 48 hours post last dose at Day 28
Reported as:
Geometric mean · hours
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207
hours25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and Simvastatin
Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY30312072.00 (1.02 to 4.00)3.00 (2.00 to 12.0)—
SecondaryPharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
Time frame:
Predose up to 48 hours post dose at Day -3 and Day 28
Reported as:
Geometric mean · nanograms/milliliter (ng/mL)
Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin
nanograms/milliliter (ng/mL)10 mg Simvastatin Day -310 mg Simvastatin Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin1.78 ± 55.33.4 ± 69.3
SecondaryPharmacokinetics: 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.

Time frame:
Predose up to 48 hours post dose at Day -3 and Day 28
Reported as:
Geometric mean · nanograms*hours/milliliter (hr*ng/mL)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin
nanograms*hours/milliliter (hr*ng/mL)10 mg Simvastatin Day -310 mg Simvastatin Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin5.23 ± 48.98.97 ± 70.1
SecondaryPharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
Time frame:
Predose up to 48 hours post dose at Day -3 and Day 28
Reported as:
Median · hours
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin
hours10 mg Simvastatin Day -310 mg Simvastatin Day 28
Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin2.00 (1.00 to 2.00)1.15 (1.08 to 2.00)
SecondaryChange 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

No measurements were reported for this outcome.

SecondaryChange 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

No measurements were reported for this outcome.

SecondaryChange 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

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo With or Without Simvastatin—0/6 (0%)1/6 (16.7%)
25 mg LY3031207—0/8 (0%)3/8 (37.5%)
75 mg LY3031207 and Simvastatin—0/10 (0%)5/10 (50%)
225 mg LY3031207 and Simvastatin—2/9 (22.2%)9/9 (100%)
400 mg Celecoxib With or Without Simvastatin—0/6 (0%)1/6 (16.7%)
10 mg Simvastatin—0/27 (0%)3/27 (11.1%)
Most frequent serious events
Most frequent serious events
EventPlacebo With or Without Simvastatin25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and Simvastatin400 mg Celecoxib With or Without Simvastatin10 mg Simvastatin
Drug-induced liver injuryHepatobiliary disorders0/60/80/102/90/60/27
Most frequent other events
Showing 10 of 27
Most frequent other events
EventPlacebo With or Without Simvastatin25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and Simvastatin400 mg Celecoxib With or Without Simvastatin10 mg Simvastatin
HeadacheNervous system disorders0/61/81/104/90/61/27
NauseaGastrointestinal disorders0/60/82/103/90/60/27
Drug-induced liver injuryHepatobiliary disorders0/60/81/103/90/60/27
DiarrhoeaGastrointestinal disorders0/61/80/102/90/60/27
Oral herpesInfections and infestations0/60/80/102/90/60/27
UrticariaSkin and subcutaneous tissue disorders0/60/80/102/90/60/27
Sensitivity of teethGastrointestinal disorders1/60/80/100/90/60/27
FatigueGeneral disorders0/60/80/101/91/60/27
IrritabilityGeneral disorders0/60/80/100/91/60/27
Viral upper respiratory tract infectionInfections and infestations0/61/81/100/90/60/27

Baseline characteristics

Participants who received at least dose of study drug.

Age, Continuous
Age, Continuous(years)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without SimvastatinTotal
Mean37.8 ± 11.839.0 ± 11.545.1 ± 14.752.7 ± 5.844.0 ± 7.843.0 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without SimvastatinTotal
Female124209
Male7854630
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without SimvastatinTotal
Hispanic or Latino100001
Not Hispanic or Latino71096638
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without SimvastatinTotal
American Indian or Alaska Native000000
Asian2233212
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White5632420
More than one race123107
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(Participants)25 mg LY303120775 mg LY3031207 and Simvastatin225 mg LY3031207 and SimvastatinPlacebo With or Without Simvastatin400 mg Celecoxib With or Without SimvastatinTotal
United States81096639
08

Study locations

1 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, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01632566
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 3, 2012
Start date
Jun 2012
Primary completion
Apr 2013
Completion
Apr 2013
Results posted
Jun 27, 2019
Last update
Jun 27, 2019

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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