Healthy VolunteersPhase 1NCT01591330
A Study of LY2140023 in Healthy Males and Females
A Phase 1 study testing LY2140023 Reference form, LY2140023 Test-Low and LY2140023 Test-Medium in people with Healthy Volunteers, run by Denovo Biopharma LLC at 1 site in United Kingdom.
Trial summary
The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses. This study will last approximately 60 days not including screening. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY2140023 Reference form, LY2140023 Test-Low and LY2140023 Test-Medium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are 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 for 3 months following the last dose of LY2140023 and agree not to donate sperm for 3 months following the last dose of LY2140023
- female participants:
- female participants of child-bearing potential who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last dose of LY2140023
- female participants who are of non-childbearing potential (that is, postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or confirmed tubal occlusion [not tubal ligation]). Postmenopausal is defined as no menses for at least 1 year, or a plasma follicle stimulating hormone (FSH) value of >40 milli-international units per liter (mIU/mL), unless the participant is taking hormone replacement therapy
- have a body mass index (BMI) of 19 to 32 kilograms per meter squared (kg/m^2), inclusive, at the time of screening
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- have clinical laboratory test results within normal reference ranges for the population or investigator site or results with acceptable deviations that are judged to be not clinically significant by the investigator
- have venous access sufficient to allow for blood sampling as per the protocol
- 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 chosen ethical review board (ERB)
Who cannot join
- are currently enrolled in or have completed or discontinued within the last 90 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- have known allergies to LY2140023, LY404039, related compounds, or any components of the formulation
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2140023 and have previously received the investigational product
- have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- have an abnormal blood pressure or pulse rate as determined by the investigator
- have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, 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
Show all 30Show fewer
- have evidence or any history of significant active neuropsychiatric disease
- have increased risk of seizures based on a history of:
- one or more seizures (except for a single simple febrile seizure [lacking focality and lasting less than 15 minutes, not associated with a central nervous system (CNS) infection or severe metabolic disturbance] as a child between ages 6 months to 5 years)
- head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
- uncontrolled migraine or transient ischemic attack (TIA) within 1 year and/or stroke with persistent neurological deficit (focal or diffuse); uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning; TIA is defined as "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
- CNS infection with persistent neurological deficit (focal or diffuse)
- brain surgery
- electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally defined)
- brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (except hydrocephalus treated by shunt or without neurological deficits).
- show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis) or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- show evidence of human immunodeficiency (HIV) virus infection and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- intend to use over-the-counter (OTC) or prescription medication within 14 days prior to dosing of LY2140023
- have donated blood of more than 500 milliliters (mL) within the 3 months prior to screening, or plan to donate blood within the 3 months after the last dose
- have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption for 48 hours prior to check-in for each treatment period until discharge in each period (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- have a clinically significant abnormality in the neurological examination
- participants judged prior to randomization to be at suicidal risk by the investigator
- participants who are unwilling to refrain from tobacco- or nicotine-containing products while in the Clinical Research Unit (CRU) or are unable to abide by CRU restrictions
- show evidence of pruritus or skin exfoliation
- have an eosinophil count > 1.5 x 10^9 per liter (L)
- show evidence of active renal disease or creatinine clearance (CrCl) less than 90 milliliters per minute (mL/min) (as calculated by the Cockcroft-Gault equation)
- in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 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.
Leeds, West Yorkshire
About this study
Official title: A Particle Size Study of 3 Different Particle Size Test Tablet Formulations Compared to the Reference Tablet Formulation in Healthy Subjects
The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses. This study will last approximately 60 days not including screening. Screening is required within 30 days prior to study entry.
- Conditions
- Healthy Volunteers
- Being tested
- LY2140023 Reference form, LY2140023 Test-Low, LY2140023 Test-Medium, LY2140023 Test-High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2140023 Reference formDrug
Also called LY2140023 Monohydrate (Reference)
80-mg tablet administered orally
LY2140023 Test-LowDrug
Also called LY2140023 Monohydrate (Test - Low)
80-mg tablet administered orally
LY2140023 Test-MediumDrug
Also called LY2140023 Monohydrate (Test - Medium)
80-mg tablet administered orally
LY2140023 Test-HighDrug
Also called LY2140023 Monohydrate (Test - High)
80-mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY2140023 Reference Form | Experimental | LY2140023: 80 mg, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. Receives: Drug: LY2140023 Reference form |
| LY2140023 Test-Low | Experimental | LY2140023: 80 mg, low particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. Receives: Drug: LY2140023 Test-Low |
| LY2140023 Test-Medium | Experimental | LY2140023: 80 mg, medium particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. Receives: Drug: LY2140023 Test-Medium |
| LY2140023 Test-High | Experimental | LY2140023: 80 mg, high particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. Receives: Drug: LY2140023 Test-High |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum Concentration (Cmax) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Secondary outcomes (8)
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Terminal Half Life (t1/2) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Apparent Total Body Clearance (CL/F) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Volume of Distribution During the Terminal Phase (Vz/F) of LY2140023
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Time of Maximum Observed Drug Concentrations (Tmax) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Terminal Half Life (t1/2) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Apparent Total Body Clearance (CL/F) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Volume of Distribution During the Terminal Phase (Vz/F) of LY404039 (Active Moiety)
Measured: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionAug 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denovo Biopharma LLC
- 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
- NCT01591330
- Sponsor's protocol ID
- 12857
- Other IDs
- H8Y-MC-HBCY
- Status last verified
- Jul 2012
- First submitted
- 2 May 2012
- Last updated
- 21 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Particle Size Study of 3 Different Particle Size Test Tablet Formulations Compared to the Reference Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01591330
- Acronym / sponsor ID
- 12857
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Denovo Biopharma LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 May 2012 (estimated)
- Results
- Posted 21 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the effect of different particle size of LY2140023. The study involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a washout period of at least 3 days between doses. This study will last approximately 60 days not including screening. Screening is required within 30 days prior to study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY2140023 Reference Form | Experimental | Drug: LY2140023 Reference formLY2140023: 80 mg, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. |
| LY2140023 Test-Low | Experimental | Drug: LY2140023 Test-LowLY2140023: 80 mg, low particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. |
| LY2140023 Test-Medium | Experimental | Drug: LY2140023 Test-MediumLY2140023: 80 mg, medium particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. |
| LY2140023 Test-High | Experimental | Drug: LY2140023 Test-HighLY2140023: 80 mg, high particle size, administered once, orally. There is a minimum 3-day washout period between dosing in one period and dosing in the next dosing period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- are 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 for 3 months following the last dose of LY2140023 and agree not to donate sperm for 3 months following the last dose of LY2140023
- female participants:
- have a body mass index (BMI) of 19 to 32 kilograms per meter squared (kg/m^2), inclusive, at the time of screening
- have clinical laboratory test results within normal reference ranges for the population or investigator site or results with acceptable deviations that are judged to be not clinically significant by the investigator
Key exclusion criteria (30 listed)
- are currently enrolled in or have completed or discontinued within the last 90 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- have known allergies to LY2140023, LY404039, related compounds, or any components of the formulation
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2140023 and have previously received the investigational product
- have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- have an abnormal blood pressure or pulse rate as determined by the investigator
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 |
|---|---|---|
| LY2140023 Reference formAlso: LY2140023 Monohydrate (Reference)80-mg tablet administered orally | Drug | LY2140023 Reference Form |
| LY2140023 Test-LowAlso: LY2140023 Monohydrate (Test - Low)80-mg tablet administered orally | Drug | LY2140023 Test-Low |
| LY2140023 Test-MediumAlso: LY2140023 Monohydrate (Test - Medium)80-mg tablet administered orally | Drug | LY2140023 Test-Medium |
| LY2140023 Test-HighAlso: LY2140023 Monohydrate (Test - High)80-mg tablet administered orally | Drug | LY2140023 Test-High |
Primary outcome
Pharmacokinetics: Maximum Concentration (Cmax) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Last Time Point of Measurable Concentration (AUC[0-tlast]) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
8 secondary outcomes
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Terminal Half Life (t1/2) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Apparent Total Body Clearance (CL/F) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Volume of Distribution During the Terminal Phase (Vz/F) of LY2140023
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Time of Maximum Observed Drug Concentrations (Tmax) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Terminal Half Life (t1/2) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Apparent Total Body Clearance (CL/F) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Pharmacokinetics: Volume of Distribution During the Terminal Phase (Vz/F) of LY404039 (Active Moiety)
Time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- 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 LY2140023 Reference form, LY2140023 Test-Low and LY2140023 Test-Medium in people with Healthy Volunteers, run by Denovo Biopharma LLC at 1 site in United Kingdom.
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 30 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 21 Sep 2021. 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 Kingdom. 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. 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 21 Sep 2021). 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?
Pharmacokinetics: Maximum Concentration (Cmax) of LY2140023 (time frame: Predose and at 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, and 24 hours postdose). The study lists 4 primary outcomes in all. 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 21 Sep 2021.