Depressive Disorder, MajorPhase 1NCT01389765
A Study to Evaluate the Effect of Food on LY2216684
A Phase 1 study testing LY2216684 in people with Depressive Disorder, Major, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- LY2216684
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Aug 2011
- 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
- Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 4 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause [at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 mIU/mL (milli-international-units/milliliter)]
- All Subjects:
- Are overtly healthy as determined by medical history and physical examination
- Have a body weight >50 kg (kilogram)
- Have 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
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- 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 institutional review board (IRB) governing the site
- Have normal blood pressure (BP) and pulse rate (sitting position)
- Are willing to eat all components in the standard high-fat meal
Who cannot join
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; 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 LY2216684, related compounds, or any components of the formulation
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
- 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 a history of suicidal ideation or suicide attempts
- Have a history of/or current 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
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- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) 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 or prescription medication within 14 days prior to dosing unless deemed acceptable by the investigator and sponsor's medical monitor, except for influenza vaccinations
- Have donated blood of more than 500 mL (milliliter) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to dosing in each period until discharge in each period [1 unit = 12 oz (ounces) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
- Consume 5 or more cups of coffee (or other beverages or foods of comparable caffeine content) per day, on a habitual basis, or are unwilling to stop caffeine consumption from 48 hours prior to dosing in each period until discharge in each period
- Subjects must adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU
- Have consumed grapefruit or grapefruit-containing products, starfruit, or pomegranates 7 days prior to enrollment or are unwilling to avoid them during the study
- Subjects determined to be unsuitable by the investigator for any reason
- Have a documented or suspected history of glaucoma
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.
Daytona Beach, Florida, 32117
About this study
Official title: Effect of Food on the Pharmacokinetics of LY2216684 in Healthy Subjects
This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.
- Conditions
- Depressive Disorder, Major
- Being tested
- LY2216684
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2216684Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY2216684 administered in fasted then fed state | Experimental | Period 1: Single 18-mg (milligram) oral dose of LY2216684 administered in fasted state. Period 2: Single 18-mg oral dose of LY2216684 administered in fed state. Periods will be separated by a minimum of 7 days. Receives: Drug: LY2216684 |
| LY2216684 administered in fed then fasted state | Experimental | Period 1: Single 18-mg oral dose of LY2216684 administered in fed state. Period 2: Single 18-mg oral dose of LY2216684 administered in fasted state. Periods will be separated by a minimum of 7 days. Receives: Drug: LY2216684 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 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 posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
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 Depressive Disorder, MajorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01389765
- Sponsor's protocol ID
- 12620
- Other IDs
- H9P-EW-LNDC
- Status last verified
- Nov 2018
- First submitted
- 6 Jul 2011
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food on the Pharmacokinetics of LY2216684 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01389765
- Acronym / sponsor ID
- 12620
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of food on LY2216684. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2216684 administered in fasted then fed state | Experimental | Drug: LY2216684Period 1: Single 18-mg (milligram) oral dose of LY2216684 administered in fasted state. Period 2: Single 18-mg oral dose of LY2216684 administered in fed state. Periods will be separated by a minimum of 7 days. |
| LY2216684 administered in fed then fasted state | Experimental | Drug: LY2216684Period 1: Single 18-mg oral dose of LY2216684 administered in fed state. Period 2: Single 18-mg oral dose of LY2216684 administered in fasted state. Periods will be separated by a minimum of 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 4 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause [at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 mIU/mL (milli-international-units/milliliter)]
- All Subjects:
Key exclusion criteria (19 listed)
- Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; 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 LY2216684, related compounds, or any components of the formulation
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
- 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 a history of suicidal ideation or suicide attempts
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 |
|---|---|---|
| LY2216684Administered orally | Drug | LY2216684 administered in fasted then fed state, LY2216684 administered in fed then fasted state |
Primary outcome
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- 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 LY2216684 in people with Depressive Disorder, Major, 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 11 inclusion and 19 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 13 Nov 2018. 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. 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 13 Nov 2018). 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: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose). The study lists 3 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 13 Nov 2018.