Major Depressive DisorderPhase 1NCT01266590

A Study of LY2216684 and Digoxin in Healthy Subjects

A Phase 1 study testing LY2216684 and Digoxin 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 determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with LY2216684. 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: Major Depressive Disorder
What is being tested?: LY2216684 and Digoxin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2010to Feb 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 and for 1 month 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 and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] greater than (>) 40 milli-International Units/milliliter (mIU/mL).
Have a body weight >50 kilograms (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 (potassium, magnesium, and calcium values must be within the normal range).
Have normal renal function defined as an estimated creatinine clearance of at least 80 milliliters/minute (mL/min) as calculated with the Cockcroft-Gault equation.

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Have venous access sufficient to allow blood sampling as per the protocol.
Have normal blood pressure and pulse rate (sitting position) as determined by the investigator.
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 ethical review board (ERB) governing the site.

Who cannot join

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, 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, digoxin, or related compounds.
Are persons who have previously 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 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 significant dysrhythmias or atrioventricular (AV) block.

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Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation.
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 (including hormonal contraceptives) within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor, except for influenza vaccinations.
Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of P-glycoprotein (P-gp) and Cytochrome (P45) (CYP) within 30 days prior to dosing.
Have donated blood of more than 500 milliliters (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 check-in until 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 participant 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 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.
Daytona Beach, Florida

Other trials in United States

About this study

Official title: Effect of LY2216684 on the Pharmacokinetics of Digoxin in Healthy Subjects

Conditions: Major Depressive Disorder
Being tested: LY2216684, Digoxin
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
DigoxinDrug
Administered orally

Study groups in NCT01266590
Study group	Role	What they receive
LY2216684 + digoxin	Experimental	Two oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14. Receives: Drug: LY2216684; Drug: Digoxin

What is being measured

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

Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)
Cmax of digoxin when administered alone and when co-administered with LY2216684.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)
Tmax of digoxin when administered alone and when co-administered with LY2216684.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)
AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14

Timeline

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

Dec 2010Feb 2011

First posted24 Dec 2010 (estimated)
Study startDec 2010
Primary completionFeb 2011
Study completionFeb 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01266590
Sponsor's protocol ID: 12600
Other IDs: H9P-EW-LNCK
Status last verified: Mar 2018
First submitted: 20 Dec 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 Major Depressive Disorder 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: Effect of LY2216684 on the Pharmacokinetics of Digoxin in Healthy Subjects
ClinicalTrials.gov ID: NCT01266590
Acronym / sponsor ID: 12600
Conditions: Major Depressive Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 24 Dec 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2216684 + digoxin	Experimental	Drug: LY2216684, Drug: DigoxinTwo oral 0.5-milligrams (mg) (two 0.25-mg tablets) doses of digoxin separated by 12 hours on Day 1, followed by once daily 0.25-mg (single 0.25-mg tablet) dose of digoxin on Days 2-14. Daily oral 18-mg (two 9-mg tablets) doses of LY2216684 on Days 8-14.

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 and for 1 month 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 and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] greater than (>) 40 milli-International Units/milliliter (mIU/mL).
Have a body weight >50 kilograms (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 (potassium, magnesium, and calcium values must be within the normal range).

Key exclusion criteria (21 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, 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, digoxin, or related compounds.
Are persons who have previously 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 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
LY2216684Administered orally	Drug	LY2216684 + digoxin
DigoxinAdministered orally	Drug	LY2216684 + digoxin

Primary outcome

Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Cmax of digoxin when administered alone and when co-administered with LY2216684.
Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
Tmax of digoxin when administered alone and when co-administered with LY2216684.
Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14
AUCt at steady state of digoxin when administered alone and when co-administered with LY2216684.

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 + Digoxin	30	24

Primary outcome: Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14. Geometric mean (90% Confidence Interval). Unit: nanograms/milliliter (ng/mL)

Measure	Digoxin n = 27	LY2216684 + Digoxin n = 25
Value	1.433 (1.266 to 1.622)	1.424 (1.254 to 1.617)

Population analysed: All participants who received at least 1 dose of study drug and had evaluable Cmax values.

Primary outcome: Pharmacokinetics of Digoxin: Time to Maximum Plasma Concentration (Tmax)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14. Median (Full Range). Unit: hours

Measure	Digoxin n = 25	LY2216684 + Digoxin n = 25
Value	2.00 (0.50 to 3.00)	1.00 (0.50 to 4.00)

Digoxin vs LY2216684 + Digoxin: p = 0.0664, Wilcoxon Signed Rank

Population analysed: All participants who received at least 1 dose of study drug and had evaluable Tmax values.

Primary outcome: Pharmacokinetics of Digoxin: Area Under the Concentration Time Curve at Steady State Over the Dosing Interval (AUCt)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14. Geometric mean (90% Confidence Interval). Unit: hours*nanograms/milliliter (h*ng/mL)

Measure	Digoxin n = 27	LY2216684 + Digoxin n = 25
Value	14.6 (13.2 to 16.1)	14.3 (12.9 to 15.8)

Population analysed: All participants who received at least 1 dose of study drug and evaluable AUCt values.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digoxin 0.5mg	0 of 30 (0%)	3 of 30 (10%)	Not reported
Digoxin 0.25mg	0 of 28 (0%)	4 of 28 (14.3%)	Not reported
LY2216684 + Digoxin	0 of 27 (0%)	16 of 27 (59.3%)	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

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 Digoxin 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 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 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?

Pharmacokinetics of Digoxin: Maximum Plasma Concentration (Cmax) (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 7 and 14). 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 NCT01266590.

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.