Depressive Disorder, MajorPhase 1NCT01241435

A Study of LY2216684 in Participants With Impaired Hepatic Function

A Phase 1 study testing LY2216684 in people with Depressive Disorder, Major, run by Eli Lilly and Company at 3 sites 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 evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. 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: 36 participants
Where: 3 sitesUnited States
Study dates: Oct 2010to Apr 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 participants: Agree to use a reliable method of birth control during the study and for 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, who have used a reliable method of birth control for 6 weeks prior to administration of study drug, and who agree to use a reliable method of birth control during the study and for 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 follicle stimulating hormone [FSH] levels greater than or equal to 40 milli-internation units per milliliter [mIU/mL]).
Have a body mass index (BMI) of 17.0 to 35.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
Have acceptable blood pressure and pulse rate (sitting) as determined by the investigator.
Have venous access sufficient to allow blood sampling as per the protocol.
Are reliable and willing to make themselves available for the duration of the study and to follow study procedures.

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Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site.
Control Participants (Participants with Normal Hepatic Function):
Are overtly healthy, as determined by medical history and physical examination.
Have clinical laboratory test results within normal reference ranges for the investigative site or results with acceptable deviations, which are judged to be not clinically significant by the investigator, at the time of screening.
Participants with Mild, Moderate, or Severe Hepatic Impairment:
Participants with stable liver disease (alcoholic liver disease, post-hepatitis, biliary cirrhosis, cryptogenic) classified as Child-Pugh score A, B, or C (Pugh et al. 1973).
Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant or of no additional clinical significance for this study.

Who cannot join

All Participants:
Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a 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 or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 in the past 6 months from screening.
Have an electrocardiogram (ECG) reading considered clinically significant by the investigator or a history of significant cardiac dysrhythmia or conduction defect that, in the opinion of the investigator, increases the risks associated with participating in the study.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.

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There is evidence or history of neurological disease such as transient ischemic attack, stroke, syncope episodes, encephalitis, or meningitis, except participants with liver disease-related encephalopathy may be allowed.
Presence of acute infection with fever.
Are women with a positive pregnancy test or women who are lactating.
Have lost 500 milliliters (mL) or more of blood in the 3 months prior to study entry.
Are participants who have an average weekly alcohol intake that exceeds 21 units per week, or are unwilling to adhere to restrictions during the study (1 unit = 12 ounces [oz] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits).
Are participants who are unwilling to adhere to study caffeine restrictions.
Are participants who are unwilling to abide by smoking restrictions while resident in the clinical research unit (CRU).
Have a documented or suspected history of glaucoma.
Control Participants (Participants with Normal Hepatic Function):
Have significant active hematological disease, history of significant active bleeding, or coagulation disorder.
Use or intend to use over-the-counter (including vitamins/mineral supplements, herbal medicine) or prescription medications 14 days, prior to enrollment and during the study.
Have history or presence of cardiovascular, respiratory, 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.
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Evidence of hepatitis C and/or positive hepatitis C antibody.
Evidence of hepatitis B and/or positive hepatitis B surface antigen.
Show evidence of significant active neuropsychiatric disease.
Participants with Mild, Moderate, or Severe Hepatic Impairment:
Evidence of any significant active disease other than that responsible for or associated with liver impairment.
Have history or presence of cardiovascular, respiratory, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
Evidence of hepatorenal syndrome.
Spontaneous bacterial peritonitis within 6 months of study entry.
Variceal bleeding within 3 months of study entry.
Severe hyponatremia (sodium [Na] <120 millimole per liter [mmol/L]).
Presence of hepatocellular carcinoma.
Severe encephalopathy.
Hemoglobin <9.0 grams per deciliter (g/dL).
Platelet count <50 x 10^9 cells per liter (cells/L), values <50 x 10^9 cells/L may be permitted at the discretion of the investigator in consultation with the sponsor.
Concomitant use of any drug except those indicated for the treatment of liver disease or related complications.
Concomitant use of anticoagulants including warfarin.
Regular use of drugs of abuse and/or positive findings on urinary drug screening except those prescribed for related complications (such as, pain, insomnia, or anxiety) of liver disease.
The use of medication known to interfere with hepatic metabolism (such as, barbiturates or phenothiazines) or known to alter other major organs or systems within 30 days prior to study entry.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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.
Miami, Florida, 33014
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.
Orlando, Florida, 32809
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.
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: The Effect of Impaired Hepatic Function on the Pharmacokinetics of LY2216684

The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study.

The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.

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
Also called Edivoxetine
Administered orally

Study groups in NCT01241435
Study group	Role	What they receive
LY2216684	Experimental	LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C) Receives: Drug: LY2216684

What is being measured

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

Pharmacokinetics: Area Under the Concentration Curve (AUC)
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC [0-∞]) for LY2216684 is presented.
Measured: Up to 72 hours after administration of study drug
Pharmacokinetics: Maximum Concentration (Cmax)
Measured: Up to 72 hours after administration of study drug
Pharmacokinetics: Time to Maximum Concentration (Tmax)
Measured: Up to 72 hours after administration of study drug

Timeline

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

Oct 2010Apr 2011

First posted16 Nov 2010 (estimated)
Study startOct 2010
Primary completionApr 2011
Study completionApr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01241435
Sponsor's protocol ID: 12602
Other IDs: H9P-EW-LNCM
Status last verified: Mar 2018
First submitted: 12 Nov 2010
Last updated: 22 Oct 2018
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?

See locations

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All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Impaired Hepatic Function on the Pharmacokinetics of LY2216684
ClinicalTrials.gov ID: NCT01241435
Acronym / sponsor ID: 12602
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 16 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.

The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.

Study design

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

Arm	Type	Receives
LY2216684	Experimental	Drug: LY2216684LY2216684: A single dose of 18 milligrams (mg) administered orally in participants with normal hepatic function, mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), or severe hepatic impairment (Child-Pugh C)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male participants: Agree to use a reliable method of birth control during the study and for 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, who have used a reliable method of birth control for 6 weeks prior to administration of study drug, and who agree to use a reliable method of birth control during the study and for 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 follicle stimulating hormone [FSH] levels greater than or equal to 40 milli-internation units per milliliter [mIU/mL]).
Have a body mass index (BMI) of 17.0 to 35.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
Have acceptable blood pressure and pulse rate (sitting) as determined by the investigator.
Have venous access sufficient to allow blood sampling as per the protocol.

Key exclusion criteria (37 listed)

Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a 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 or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 in the past 6 months from screening.
Have an electrocardiogram (ECG) reading considered clinically significant by the investigator or a history of significant cardiac dysrhythmia or conduction defect that, in the opinion of the investigator, increases the risks associated with participating in the study.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.

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	LY2216684

Primary outcome

Pharmacokinetics: Area Under the Concentration Curve (AUC)
Time frame: Up to 72 hours after administration of study drug
The area under the plasma concentration versus time curve from 0 hours to infinity (AUC [0-∞]) for LY2216684 is presented.
Pharmacokinetics: Maximum Concentration (Cmax)
Time frame: Up to 72 hours after administration of study drug
Pharmacokinetics: Time to Maximum Concentration (Tmax)
Time frame: Up to 72 hours after administration of study drug

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
Normal Hepatic Function	12	12
Mild Hepatic Impairment	8	8
Moderate Hepatic Impairment	8	8
Severe Hepatic Impairment	8	8

Primary outcome: Pharmacokinetics: Area Under the Concentration Curve (AUC)

Time frame: Up to 72 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: hours times nanograms/milliliter

Measure	Normal Hepatic Function n = 12	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 8
Value	601 (32)	742 (52)	961 (45)	1020 (16)

Population analysed: Participants who received at least one dose of study drug.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax)

Time frame: Up to 72 hours after administration of study drug. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter

Measure	Normal Hepatic Function n = 12	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 8
Value	46.8 (27)	39.6 (28)	41.9 (33)	34.7 (15)

Population analysed: Participants who received at least one dose of study drug.

Primary outcome: Pharmacokinetics: Time to Maximum Concentration (Tmax)

Time frame: Up to 72 hours after administration of study drug. Median (Full Range). Unit: hours

Measure	Normal Hepatic Function n = 12	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 8	Severe Hepatic Impairment n = 8
Value	3.00 (1.00 to 5.00)	3.50 (2.00 to 6.00)	3.50 (1.00 to 5.00)	3.50 (2.00 to 5.00)

Population analysed: Participants who received at least one dose of study drug.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Hepatic Function	0 of 12 (0%)	6 of 12 (50%)	Not reported
Mild Hepatic Impairment	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Moderate Hepatic Impairment	0 of 8 (0%)	6 of 8 (75%)	Not reported
Severe Hepatic Impairment	0 of 8 (0%)	5 of 8 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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

3 sites 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 3 sites 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 13 inclusion and 37 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Pharmacokinetics: Area Under the Concentration Curve (AUC) (time frame: Up to 72 hours after administration of study drug). 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 NCT01241435.

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 22 Oct 2018.