Healthy VolunteersPhase 1NCT01449630
A Study of LY3031207 in Healthy Subjects
A Phase 1 study testing LY3031207 and Celecoxib in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and 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. Read more about this study
- 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 and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2011to 2 Apr 2012
- 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
- Male subjects agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
- Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history or menopause
- Menopausal women include women with either spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example [e.g.], oral contraceptives, hormones, gonadotropin-releasing hormone, antiestrogens, selective estrogen receptor modulators, or chemotherapy) or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level greater than 40 milli-International Unit (mIU/mL)
- Overtly healthy based on the history and physical examinations as determined by the investigator
- Between body mass index (BMI) of 18.5 and 32.0 kilogram per meter squared (kg/m^2), inclusive
- Normotensive defined as supine systolic blood pressure (BP) <140 of millimeter mercury (mmHg), and diastolic BP <90 mmHg, without the use of any antihypertensives, or results that are judged to be not clinically significant by the Investigator. Blood pressure may be retested up to 2 additional times, under well rested conditions
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- Clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Ex vivo whole blood prostaglandin E(PGE) synthesis after lipopolysaccharide (LPS) stimulation of no less than 5 nanograms/milliliter (ng/mL).
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Who cannot join
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug with a short half-life, or within 5 half-life of an investigational product with a half-life longer than 5 days, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY3031207 or any components of the formulation, celecoxib or sulfonamides. Subjects with known aspirin allergy or allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) should also be excluded
- Are persons who have previously completed or withdrawn from this study or any other study investigating LY3031207 and who have previously received the investigational product
- Have an abnormality in the 12-lead Electrocardiogram (ECG), including QTc interval with Bazett's correction >450 millisecond (msec) for men and >470 msec for women or an abnormality that, in the opinion of the investigator, increases the risks associated with participating in the study. Electrocardiogram may be repeated after 5 minutes resting quietly, if the subject's heart rate is >75 beats per minute
- History of, within the last 2 years, or presence of active cardiovascular disease, including acute myocardial infarction, unstable angina, congestive heart failure, stroke, or transient ischemic attack
- Presence of clinically significant active bleeding or history of bleeding diathesis at the time of screening
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- Presence of active peptic ulcer disease, Gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhea, or positive H. pylori serology
- Evidence of hepatitis C and/or positive hepatitis C antibody
- Evidence of hepatitis B and/or positive hepatitis B surface antigen
- Evidence of other chronic liver disease, including chronic alcoholic disease; non-alcoholic steatohepatitis; recent (within 3 months of screening) history of acute viral hepatitis; or subjects with known Gilbert Syndrome
- History of active neuropsychiatric disease
- Evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
- Have a significant history of or current other cardiovascular, respiratory (especially asthma and chronic obstructive pulmonary disease), hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. History of prior surgeries (at least 3 months prior to dosing), such as splenectomy, cholecystectomy, and appendectomy are not exclusionary
- Regularly use of known drugs of abuse and/or show positive findings on urinary drug screening
- Are women with a positive pregnancy test or women who are lactating
- Intended use of over-the-counter medications or prescription medication within 14 days prior to dosing, this includes but is not limited to antihypertensives, diuretics, antiplatelet or anticoagulant drugs, and antidepressants
- Any use of NSAIDs, celecoxib, aspirin or acetaminophen (at doses >1 gram [gm] per day) within 14 days of screening
- Any use of herbal or dietary supplements, or grapefruit and/or grapefruit juice, Seville oranges, starfruit, or pomegranate within 14 days prior to dosing of study drug
- Have donated blood of more than 500 milliliter (mL) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounce [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
- Subjects who smoke more than 10 cigarettes per day or are unwilling to follow the Clinical Research Unit (CRU) smoking rules
- Subjects with any major surgery within 30 days prior to screening or subjects with planned surgeries to occur during the study
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
About this study
Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects
This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and 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. Subjects will participate in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.
- Conditions
- Healthy Volunteers
- Being tested
- LY3031207, Placebo, Celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3031207Drug
Administered orally
PlaceboDrug
Administered orally
CelecoxibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3031207 | Experimental | Participants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally. Receives: Drug: LY3031207 |
| Placebo | Placebo comparator | Single dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose. Receives: Drug: Placebo |
| Celecoxib | Active comparator | Single 400mg dose of celecoxib administered orally on one occasion. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 1 or More Drug Related Adverse Events (AE) 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 drug relatedness, is located in the Reported Adverse Event module.
Measured: Baseline, up to 4 months
Secondary outcomes (6)
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207
AUC from time 0 to last timepoint (AUC0-tlast) with measurable concentration of LY3031207.
Measured: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
Measured: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
The effect of LY3031207 on PGE synthesis in whole blood after ex vivo LPS stimulation.
Measured: Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGEM was assessed. PGEM results for each interval were then compared to the baseline value.
Measured: 0 to 2, 2 to 4, 4 to 6, 6 to 12 and 12 to 24 hours post dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGIM was assessed. PGIM results for each interval were then compared to the baseline value.
Measured: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
The participant's urine was collected during protocol-defined intervals and the PGE metabolite TXAM was assessed. TXAM results for each interval were then compared to the baseline value.
Measured: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study start24 Oct 2011
- Primary completion2 Apr 2012
- Study completion2 Apr 2012
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449630
- Sponsor's protocol ID
- 14283
- Other IDs
- I5W-EW-LBCA
- Status last verified
- Jun 2019
- First submitted
- 5 Oct 2011
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3031207 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01449630
- Acronym / sponsor ID
- 14283
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2011 (actual)
- Primary completion
- 2 Apr 2012 (actual)
- Study completion
- 2 Apr 2012 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and 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. Subjects will participate in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3031207 | Experimental | Drug: LY3031207Participants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally. |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose. |
| Celecoxib | Active comparator | Drug: CelecoxibSingle 400mg dose of celecoxib administered orally on one occasion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male subjects agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
- Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history or menopause
- Menopausal women include women with either spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example [e.g.], oral contraceptives, hormones, gonadotropin-releasing hormone, antiestrogens, selective estrogen receptor modulators, or chemotherapy) or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level greater than 40 milli-International Unit (mIU/mL)
- Overtly healthy based on the history and physical examinations as determined by the investigator
- Between body mass index (BMI) of 18.5 and 32.0 kilogram per meter squared (kg/m^2), inclusive
Key exclusion criteria (22 listed)
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug with a short half-life, or within 5 half-life of an investigational product with a half-life longer than 5 days, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY3031207 or any components of the formulation, celecoxib or sulfonamides. Subjects with known aspirin allergy or allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) should also be excluded
- Are persons who have previously completed or withdrawn from this study or any other study investigating LY3031207 and who have previously received the investigational product
- Have an abnormality in the 12-lead Electrocardiogram (ECG), including QTc interval with Bazett's correction >450 millisecond (msec) for men and >470 msec for women or an abnormality that, in the opinion of the investigator, increases the risks associated with participating in the study. Electrocardiogram may be repeated after 5 minutes resting quietly, if the subject's heart rate is >75 beats per minute
- History of, within the last 2 years, or presence of active cardiovascular disease, including acute myocardial infarction, unstable angina, congestive heart failure, stroke, or transient ischemic attack
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 |
|---|---|---|
| LY3031207Administered orally | Drug | LY3031207 |
| PlaceboAdministered orally | Drug | Placebo |
| CelecoxibAdministered orally | Drug | Celecoxib |
Primary outcome
Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE
Time frame: Baseline, up to 4 months
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 drug relatedness, is located in the Reported Adverse Event module.
6 secondary outcomes
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207
Time frame: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
Time frame: Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
Time frame: Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 12 and 12 to 24 hours post dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)
Time frame: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose
Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)
Time frame: 0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
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 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 10 inclusion and 22 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 5 Jul 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 5 Jul 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 1 or More Drug Related Adverse Events (AE) or Any Serious AE (time frame: Baseline, up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.