Major Depressive DisorderPhase 1NCT01243957

A Study to Measure if There is Any Difference in How the Body Breaks Down or Inactivates Either Fluoxetine or LY2216684 When Both of These Medicines Are Given Together.

A Phase 1 study testing LY2216684 and Fluoxetine 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

The purpose of this study is to measure if there is any difference in how the body breaks down or inactivates either fluoxetine or LY2216684 when both of these medicines are given together. This study will look at how fluoxetine might affect LY2216684 and how giving LY2216684 might affect fluoxetine in the body. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: LY2216684 and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Jan 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

Are overtly healthy as determined by medical history and physical examination.
Male participants: Agree to use a reliable method of birth control during the study + 3 months following the last dose of study drug.
Female participants: 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 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study + 1 month following the last dose of study drug; or are 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) level ≥40 mass International Units per milliliter (mIU/mL).
Are between the ages of 18-65 years, inclusive.
Are between the body mass index (BMI) of 18.5-32.0 kilograms per square meter (kg/m^2), inclusive.
Have screening 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 blood sampling according to the protocol.
Have normal blood pressure (BP) and pulse rate (supine position and standing) as determined by the investigator.
Are reliable and available for the duration of the study and are willing to follow study procedures.
Provided written informed consent approved by Lilly and the institutional review board (IRB) governing the site.

Who cannot join

Are investigator site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Are Lilly employees.
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device 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, fluoxetine, or related compounds.
Are persons who previously completed or discontinued from this study, or any other study investigating LY2216684 within 6 months prior to screening.
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator.

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Have significant history of or current cardiovascular (including dysrhythmias), 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.
Have a history of seizure disorders.
Have a history or presence of the signs and/or symptoms of hyponatremia.
Have a history or presence of the signs and/or symptoms of hyperthyroidism as determined by an abnormal thyroid stimulating hormone (TSH) at screening.
Show evidence of significant active neuropsychiatric disease or a history of suicidal thoughts or attempted suicide.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Show evidence of human immunodeficiency virus (HIV) 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.
Use of any drugs or substances that are known to be a strong inducer or inhibitor of cytochrome P450 2D6 (CYP2D6) within 30 days prior to check-in.
Have donated blood of more than 500 milliliters (mL) within 4 weeks prior to screening.
Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to check-in until the completion of the study (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 any participants unwilling to adhere to study caffeine restrictions.
Have used any tobacco-containing or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to enrollment.
Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment and during the study.
Have a documented or suspected history of glaucoma.
Participants are 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

Other trials in United States

About this study

Official title: LY2216684 and Fluoxetine Pharmacokinetic Interaction Study in Healthy Subjects

The duration of study participation in this study is approximately 36 days not including the screening appointment. This study requires 1 research unit confinement of 29 days/28 nights followed by 1 outpatient appointment. A screening appointment is required within 30 days prior to the start of the study.

Conditions: Major Depressive Disorder
Being tested: LY2216684, Fluoxetine
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
LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27
FluoxetineDrug
Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)

Study groups in NCT01243957
Study group	Role	What they receive
LY2216684 + fluoxetine	Experimental	LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1, 2, and 3 and Days 25-27 Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27) Receives: Drug: LY2216684; Drug: Fluoxetine

What is being measured

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

Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684
The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684
The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27

Secondary outcomes (3)

Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine
The Least Squares (LS) geometric means AUCτ of fluoxetine and norfluoxetine were calculated based on the fluoxetine and norfluoxetine plasma concentration time curves from time 0 hour (hr) to time 24 hr (tau [τ]) when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY22166684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of AUCτ and the associated 90% confidence interval (CI) of the ratios were calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine
The Least Squares (LS) geometric means Cmax of fluoxetine and norfluoxetine were determined when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of Cmax and the associated 90% confidence interval (CI) of the ratios were calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine
Tmax of fluoxetine and norfluoxetine was determined using the median of paired differences between the 2 treatment groups when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27

Timeline

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

Oct 2010Jan 2011

First posted19 Nov 2010 (estimated)
Study startOct 2010
Primary completionJan 2011
Study completionJan 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243957
Sponsor's protocol ID: 12597
Other IDs: H9P-EW-LNCH
Status last verified: Jan 2019
First submitted: 17 Nov 2010
Last updated: 29 Jan 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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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LY2216684 and Fluoxetine Pharmacokinetic Interaction Study in Healthy Subjects
ClinicalTrials.gov ID: NCT01243957
Acronym / sponsor ID: 12597
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 22 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2216684 + fluoxetine	Experimental	Drug: LY2216684, Drug: FluoxetineLY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1, 2, and 3 and Days 25-27 Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)

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 as determined by medical history and physical examination.
Male participants: Agree to use a reliable method of birth control during the study + 3 months following the last dose of study drug.
Female participants: 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 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study + 1 month following the last dose of study drug; or are 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) level ≥40 mass International Units per milliliter (mIU/mL).
Are between the ages of 18-65 years, inclusive.
Are between the body mass index (BMI) of 18.5-32.0 kilograms per square meter (kg/m^2), inclusive.

Key exclusion criteria (25 listed)

Are investigator site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Are Lilly employees.
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device 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, fluoxetine, or related compounds.
Are persons who previously completed or discontinued from this study, or any other study investigating LY2216684 within 6 months prior to screening.

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
LY2216684LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27	Drug	LY2216684 + fluoxetine
FluoxetineFluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)	Drug	LY2216684 + fluoxetine

Primary outcome

Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.

3 secondary outcomes

Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27

Results and safety

Results posted to the registry on 22 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2216684 + Fluoxetine	20	20

Primary outcome: Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684

Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27. Least squares mean (90% Confidence Interval). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	LY2216684 + Fluoxetine n = 20
LY2216684 alone	677 (609 to 753)
LY2216684 + fluoxetine	1210 (1090 to 1350)

LY2216684 + Fluoxetine: Ratio of Geometric LS Means: 1.79 (90% CI 1.61 to 2.00), ANOVA

Population analysed: The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.

Primary outcome: Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684

Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27. Least squares mean (90% Confidence Interval). Unit: nanogram per milliliter (ng/mL)

Measure	LY2216684 + Fluoxetine n = 20
LY2216684 alone	55.5 (50.8 to 60.7)
LY2216684 + fluoxetine	90.6 (82.8 to 99.0)

LY2216684 + Fluoxetine: Ratio of Geometric LS Means: 1.63 (90% CI 1.49 to 1.79), ANOVA

Population analysed: The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.

Primary outcome: Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684

Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27. Median (90% Confidence Interval). Unit: hours

Measure	LY2216684 + Fluoxetine n = 20
LY2216684 alone	3.00 (1.00 to 6.00)
LY2216684 + fluoxetine	3.00 (2.00 to 4.07)

LY2216684 + Fluoxetine: Median Difference (Final Values): 0.00 (90% CI -0.50 to 0.50), p = 0.5459, Wilcoxon (Mann-Whitney)

Population analysed: The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2216684	0 of 20 (0%)	16 of 20 (80%)	Not reported
Fluoxetine	0 of 20 (0%)	13 of 20 (65%)	Not reported
LY2216684 + Fluoxetine	0 of 20 (0%)	14 of 20 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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 Fluoxetine 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 25 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 29 Jan 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 22 Oct 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?

Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684 (time frame: Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27). 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?

On the ClinicalTrials.gov record for NCT01243957.

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 29 Jan 2019.