Major Depressive DisorderPhase 1NCT01380691

A Study of LY2216684 in Healthy Participants

A Phase 1 study testing LY2216684 and Alcoholic beverage in people with Major Depressive Disorder, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: LY2216684 and Alcoholic beverage
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Sep 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 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy male or female participants, as determined by medical history and physical examination
Male participants: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Female participants: Women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 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 (hormonal methods of contraception, including oral and implantable contraceptives, are not allowed in this study) or women who are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or due to menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 milli-international units/milliliter [mIU/mL])
Male and female participants: Examples of reliable methods of birth control include double-barrier methods (for example, condom and spermicide) alone or in combination with vasectomy, vasectomized partners, and abstinence.
Have a body weight >50 kilogram (kg)
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
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 and pulse rate (in sitting position) as determined by the investigator

Who cannot join

Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product other than the study drug 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 or 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 or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that are 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
Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation

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Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Participants with a past history of alcohol dependence/abuse
Show evidence of human immunodeficiency virus (HIV) infection and/or positive 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
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 or during the study unless deemed acceptable by the investigator and Sponsor's medical monitor, except for influenza vaccinations
Have donated blood of more than 500 milliliter (mL) within the last month
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to each study period and while resident at the Clinical Research Unit (CRU) (except as required per this protocol); (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)
Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or are unwilling to adhere to study caffeine restrictions
Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment or are unwilling to abstain during the study
Have a documented or suspected history of glaucoma
Participants with known or suspected alcohol dehydrogenase deficiency
Participants who do not drink alcohol and/or are not willing to drink 4 units of alcohol over a 15-minute period
Participants determined to be unsuitable by the investigator for any reason

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

Other trials in United States

About this study

Official title: A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction of LY2216684 With Alcohol in Healthy Subjects

This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.

Conditions: Major Depressive Disorder
Being tested: LY2216684, Placebo-matching LY2216684, Placebo-matching alcoholic beverage, Alcoholic beverage
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
Also called Edivoxetine
Administered orally
Placebo-matching LY2216684Drug
Administered orally
Placebo-matching alcoholic beverageDrug
Administered orally
Alcoholic beverageDrug
Administered orally

Study groups in NCT01380691
Study group	Role	What they receive
LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc	Experimental	Period 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms [g/kg] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. Receives: Drug: LY2216684; Drug: Placebo-matching LY2216684; Drug: Placebo-matching alcoholic beverage; Drug: Alcoholic beverage
Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc	Experimental	Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2. Receives: Drug: LY2216684; Drug: Placebo-matching LY2216684; Drug: Placebo-matching alcoholic beverage; Drug: Alcoholic beverage
LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc	Experimental	Period 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. Receives: Drug: LY2216684; Drug: Placebo-matching LY2216684; Drug: Placebo-matching alcoholic beverage; Drug: Alcoholic beverage
Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc	Experimental	Period 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2. Receives: Drug: LY2216684; Drug: Placebo-matching LY2216684; Drug: Placebo-matching alcoholic beverage; Drug: Alcoholic beverage

What is being measured

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

Change From Baseline to 10 Hours in Power of Attention Composite Score
Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 10 hours
Change From Baseline to 10 Hours in Continuity of Attention Composite Score
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 10 hours
Change From Baseline to 10 Hours in Postural Stability
The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway.
The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 10 hours
Change From Baseline to 10 Hours in Self-Rated Alertness
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 10 hours

Secondary outcomes (10)

Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
Measured: Predose through 24 hours postdose
Pharmacokinetics: Observed Cmax of Alcohol
Measured: Predose through 24 hours postdose
Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
Measured: Predose through 24 hours postdose
Pharmacokinetics: Observed Tmax of Alcohol
Measured: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
Measured: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol
Measured: Predose through 12 hours postdose
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks known as the sensitivity index (SI). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
A series of 5 digits were presented on a computer screen, every second, for the participant to hold in memory. Followed by 30 probe digits, the participant had to decide whether it appeared in the original series by responding with 'Yes' or 'No'. This was repeated 2 times using different series and probes.
LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
Episodic memory is based on how accurate the participant responds using the measures from immediate word recall (range 0-15), delayed word recall (range 0-15), word recognition (range 0-15), and picture recognition (range 0-20) tasks. The sum of four the accuracy scores, are summed, and averaged to provide a composite score (range 0-37.5). This composite score reflects the ability to store, hold, and retrieve information of an episodic nature (such as an event, a name, an object, a scene, or an appointment). A high score reflects someone able to recall memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
Speed of retrieval is a measure of complex information processing speed, summing reaction times from the two working memory (numeric and spatial) tasks and the two episodic recognition (word recognition and picture recognition) tasks. This composite score reflects the time it takes to decide correctly whether an item is held in working memory or episodic secondary memory.Scores are measured by response latencies, and smaller scores indicate better function. A negative change from baseline reflects impairment compared to baseline.
LS means calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Measured: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours

Timeline

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

Jun 2011Sep 2011

First posted27 Jun 2011 (estimated)
Study startJun 2011
Primary completionSep 2011
Study completionSep 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 Major Depressive DisorderStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01380691
Sponsor's protocol ID: 12613
Other IDs: H9P-EW-LNCV
Status last verified: Apr 2019
First submitted: 22 Jun 2011
Last updated: 26 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 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction of LY2216684 With Alcohol in Healthy Subjects
ClinicalTrials.gov ID: NCT01380691
Acronym / sponsor ID: 12613
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 26 Jun 2019

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 pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc	Experimental	Drug: LY2216684, Drug: Placebo-matching LY2216684, Drug: Placebo-matching alcoholic beverage, Drug: Alcoholic beveragePeriod 1: 18 milligrams (mg) LY2216684 (LY) administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic (Alc) beverage (with an alcohol dose of 0.6 grams per kilograms [g/kg] for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching (Pl-Match) alcoholic beverage, taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2.
Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc	Experimental	Drug: LY2216684, Drug: Placebo-matching LY2216684, Drug: Placebo-matching alcoholic beverage, Drug: Alcoholic beveragePeriod 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. On Day 8, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. There was a 7-day washout period between Periods 1 and 2.
LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc	Experimental	Drug: LY2216684, Drug: Placebo-matching LY2216684, Drug: Placebo-matching alcoholic beverage, Drug: Alcoholic beveragePeriod 1: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2.
Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc	Experimental	Drug: LY2216684, Drug: Placebo-matching LY2216684, Drug: Placebo-matching alcoholic beverage, Drug: Alcoholic beveragePeriod 1: Placebo-matching LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. Period 2: 18 mg LY2216684 administered orally, once daily for 8 days. On Day 6, participants were administered 2 cups of a placebo-matching alcoholic beverage, taken orally, one time. On Day 8, participants were administered 2 cups of an alcoholic beverage (with an alcohol dose of 0.6 g/kg for women and 0.7 g/kg for men), taken orally, one time. There was a 7-day washout period between Periods 1 and 2.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Overtly healthy male or female participants, as determined by medical history and physical examination
Male participants: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Female participants: Women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 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 (hormonal methods of contraception, including oral and implantable contraceptives, are not allowed in this study) or women who are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or due to menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 milli-international units/milliliter [mIU/mL])
Male and female participants: Examples of reliable methods of birth control include double-barrier methods (for example, condom and spermicide) alone or in combination with vasectomy, vasectomized partners, and abstinence.
Have a body weight >50 kilogram (kg)

Key exclusion criteria (21 listed)

Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product other than the study drug 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 or 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 or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that are 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

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
LY2216684Also: EdivoxetineAdministered orally	Drug	LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc, LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc, Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc, Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc
Placebo-matching LY2216684Administered orally	Drug	LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc, LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc, Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc, Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc
Placebo-matching alcoholic beverageAdministered orally	Drug	LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc, LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc, Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc, Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc
Alcoholic beverageAdministered orally	Drug	LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc, LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc, Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc, Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc

Primary outcome

Change From Baseline to 10 Hours in Power of Attention Composite Score
Time frame: Baseline, 10 hours
Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Change From Baseline to 10 Hours in Continuity of Attention Composite Score
Time frame: Baseline, 10 hours
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Change From Baseline to 10 Hours in Postural Stability
Time frame: Baseline, 10 hours
The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway. The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Change From Baseline to 10 Hours in Self-Rated Alertness
Time frame: Baseline, 10 hours
Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.

10 secondary outcomes

Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Cmax of Alcohol
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Observed Tmax of Alcohol
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684
Time frame: Predose through 24 hours postdose
Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol
Time frame: Predose through 12 hours postdose
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours
Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment
Time frame: Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours

Results and safety

Results posted to the registry on 26 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
LY, Alc, Pl-Match Alc, Then Pl-Match LY, Alc, Pl-Match Alc	7	7
Pl-Match LY, Alc, Pl-Match Alc, Then LY, Alc, Pl-Match Alc	7	7
LY, Pl-Match Alc, Alc, Then Pl-Match LY, Pl-Match Alc, Alc	7	7
Pl-Match LY, Pl-Match Alc, Alc, Then LY, Pl-Match Alc, Alc	7	7

Primary outcome: Change From Baseline to 10 Hours in Power of Attention Composite Score

Time frame: Baseline, 10 hours. Least squares mean (95% Confidence Interval). Unit: minutes

Measure	LY2216684 + Alcohol n = 27	Placebo-matching LY2216684 + Alcohol n = 27	LY2216684 + Placebo-matching Alcohol n = 27	Placebo-matching LY2216684 + Placebo-matching Alcohol n = 27
Value	67.82 (22.01 to 113.63)	52.77 (7.05 to 98.5)	20.6 (-25.13 to 66.33)	6.78 (-39.13 to 52.69)

Population analysed: Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable power of attention data.

Primary outcome: Change From Baseline to 10 Hours in Continuity of Attention Composite Score

Time frame: Baseline, 10 hours. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	LY2216684 + Alcohol n = 27	Placebo-matching LY2216684 + Alcohol n = 27	LY2216684 + Placebo-matching Alcohol n = 27	Placebo-matching LY2216684 + Placebo-matching Alcohol n = 27
Value	-4.21 (-6.98 to -1.43)	-1.16 (-3.93 to 1.61)	-3.31 (-6.08 to -0.54)	-1.24 (-4 to 1.53)

Primary outcome: Change From Baseline to 10 Hours in Postural Stability

Time frame: Baseline, 10 hours. Least squares mean (95% Confidence Interval). Unit: 1/3 degree of angle of sway

Measure	LY2216684 + Alcohol n = 27	Placebo-matching LY2216684 + Alcohol n = 27	LY2216684 + Placebo-matching Alcohol n = 27	Placebo-matching LY2216684 + Placebo-matching Alcohol n = 27
Value	0.14 (-5.38 to 5.66)	-3.51 (-9.03 to 2)	-3.65 (-9.17 to 1.87)	5.2 (-0.32 to 10.72)

Primary outcome: Change From Baseline to 10 Hours in Self-Rated Alertness

Time frame: Baseline, 10 hours. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	LY2216684 + Alcohol n = 27	Placebo-matching LY2216684 + Alcohol n = 27	LY2216684 + Placebo-matching Alcohol n = 27	Placebo-matching LY2216684 + Placebo-matching Alcohol n = 27
Value	3.85 (-4.25 to 11.95)	-2.37 (-10.47 to 5.72)	11.88 (3.77 to 19.98)	3.02 (-5.1 to 11.14)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2216684 + Placebo-matching Alcohol	0 of 27 (0%)	16 of 27 (59.3%)	Not reported
Placebo-matching LY2216684 + Placebo-matching Alcohol	0 of 27 (0%)	8 of 27 (29.6%)	Not reported
LY2216684 + Alcohol	0 of 27 (0%)	10 of 27 (37%)	Not reported
Placebo-matching LY2216684 + Alcohol	0 of 27 (0%)	8 of 27 (29.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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 LY2216684 and Alcoholic beverage in people with Major Depressive Disorder, 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 21 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 26 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. 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 26 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?

Change From Baseline to 10 Hours in Power of Attention Composite Score (time frame: Baseline, 10 hours). 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?

On the ClinicalTrials.gov record for NCT01380691.

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 26 Jun 2019.