Depressive Disorder, MajorPhase 1NCT01460381

A Study to Evaluate the Effect of Genotype on LY2216684

A Phase 1 study testing LY2216684 and Quinidine in people with Depressive Disorder, Major, 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

Search all trials

Trial summary

The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented. 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 and Quinidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Aug 2012
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 males or females, 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 (not including hormonal contraceptives) for 4 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of the study drug or; Are women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] level >40 milli-international units per 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
Have venous access sufficient to allow for blood sampling as per the protocol

Show all 11Show fewer

Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site
Have normal blood pressure (BP) and pulse rate (PR) (sitting position) as determined by the investigator
Are predicted to have cytochrome P450 (CYP)2C19 extensive metabolizer (EM) or poor metabolizer (PM) phenotypes as determined by genotyping assessment
Are predicted to have CYP2D6 EM phenotype as determined by genotyping assessment.

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; 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/intolerance to LY2216684 or quinidine, 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 or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation
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

Show all 20Show fewer

Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Are women with a positive pregnancy test or women who are lactating
Intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study unless deemed acceptable by the investigator and Sponsor's medical monitor. Exceptions include influenza vaccinations, the use of topical medication (provided there is no evidence of chronic dosing with the risk of systemic exposure), occasional use of acetaminophen/paracetamol/ibuprofen, and hormone replacement therapy including thyroid replacement (stable dose for at least 1 month).
Have donated blood of more than 500 milliliters (mL) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing in Period 1 until Discharge (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)
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
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 stop caffeine consumption from 48 hours prior to dosing in Period 1 until Discharge
Have consumed grapefruit or grapefruit-containing products 30 days prior to enrollment or unwilling to abstain during the study
Have a documented or suspected history of glaucoma
Participants unwilling to adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU
Use of known inhibitors and/or inducers of CYP2C19 and CYP2D6 (with the exception of quinidine per protocol) 30 days prior to enrollment or are unwilling to avoid them during the study.

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.
Dallas, Texas

Other trials in United States

About this study

Official title: A Study to Investigate the Effect of CYP2C19 Phenotype on the Pharmacokinetics of LY2216684 in Healthy Subjects

The study will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented.

Read the detailed description

The human cytochrome P450 2C19 (CYP2C19) enzyme is a polymorphic enzyme yielding ultrarapid metabolizer, extensive metabolizer (EM), intermediate metabolizer, and poor metabolizer (PM) phenotypes. Enrollment in the study was limited to participants predicted to be CYP2C19 extensive metabolizers or CYP2C19 poor metabolizers, as determined by genotyping analysis.

Conditions: Depressive Disorder, Major
Being tested: LY2216684, Quinidine
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
QuinidineDrug
Also called Quinidine sulfate controlled release (CR)

Study groups in NCT01460381
Study group	Role	What they receive
LY2216684 + Quinidine (CYP2C19 poor metabolizers)	Experimental	Participants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis. Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 was administered on Day 1. Period 2 (Days 8-15): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11. Receives: Drug: LY2216684; Drug: Quinidine
LY2216684 (CYP2C19 extensive metabolizers)	Experimental	Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) phenotype, as determined by genotyping analysis. Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 administered on Day 1. Period 2 (Days 8-15): EM participants did not participate in this period. Receives: Drug: LY2216684

What is being measured

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

Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of LY2216684
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of LY2216684
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of LY2216684

Secondary outcomes (3)

Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [(AUC(0-∞)] of LY2216684 + Quinidine in Cytochrome P450 (CYP)2C19 Poor Metabolizers (PM)
Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of quinidine
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers
Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of quinidine
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers
Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.
Measured: Predose up to 120 hours post administration of quinidine

Timeline

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

Oct 2011Aug 2012

First posted26 Oct 2011 (estimated)
Study startOct 2011
Primary completionAug 2012
Study completionAug 2012

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01460381
Sponsor's protocol ID: 14397
Other IDs: H9P-EW-LNDZ
Status last verified: Mar 2018
First submitted: 24 Oct 2011
Last updated: 26 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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Effect of CYP2C19 Phenotype on the Pharmacokinetics of LY2216684 in Healthy Subjects
ClinicalTrials.gov ID: NCT01460381
Acronym / sponsor ID: 14397
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 26 Oct 2011 (estimated)
Results: Posted 26 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 will evaluate how genetic profiles respond to LY2216684 and the effect of Quinidine on the pharmacokinetics (PK) of LY2216684 in a specific genetic profile. Side effects will be documented.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LY2216684 + Quinidine (CYP2C19 poor metabolizers)	Experimental	Drug: LY2216684, Drug: QuinidineParticipants were predicted to have a cytochrome P450 (CYP)2C19 poor metabolizer (PM) phenotype, as determined by genotyping analysis. Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 was administered on Day 1. Period 2 (Days 8-15): 300 mg quinidine sulfate controlled release was administered orally, once daily on Days 8-15. Additionally, a single, oral dose of 18 mg LY2216684 was administered on Day 11.
LY2216684 (CYP2C19 extensive metabolizers)	Experimental	Drug: LY2216684Participants were predicted to have a cytochrome P450 (CYP)2C19 extensive metabolizer (EM) phenotype, as determined by genotyping analysis. Period 1 (Days 1-7): a single, oral dose of 18 milligrams (mg) LY2216684 administered on Day 1. Period 2 (Days 8-15): EM participants did not participate in this period.

Who may qualify

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

Key inclusion criteria (11 listed)

Are overtly healthy males or females, 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 (not including hormonal contraceptives) for 4 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of the study drug or; Are women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] level >40 milli-international units per 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

Key exclusion criteria (20 listed)

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; 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/intolerance to LY2216684 or quinidine, 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 or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation

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
LY2216684	Drug	LY2216684 (CYP2C19 extensive metabolizers), LY2216684 + Quinidine (CYP2C19 poor metabolizers)
QuinidineAlso: Quinidine sulfate controlled release (CR)	Drug	LY2216684 + Quinidine (CYP2C19 poor metabolizers)

Primary outcome

Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Time frame: Predose up to 120 hours post administration of LY2216684
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Time frame: Predose up to 120 hours post administration of LY2216684
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)
Time frame: Predose up to 120 hours post administration of LY2216684
Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.

3 secondary outcomes

Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [(AUC(0-∞)] of LY2216684 + Quinidine in Cytochrome P450 (CYP)2C19 Poor Metabolizers (PM)
Time frame: Predose up to 120 hours post administration of quinidine
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers
Time frame: Predose up to 120 hours post administration of quinidine
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers
Time frame: Predose up to 120 hours post administration of quinidine

Results and safety

Results posted to the registry on 26 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 + Quinidine (CYP2C19 Poor Metabolizers)	7	7
LY2216684 (CYP2C19 Extensive Metabolizers)	11	11

Primary outcome: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)

Time frame: Predose up to 120 hours post administration of LY2216684. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter (ng*h/mL)

Measure	LY2216684 (CYP2C19 Poor Metabolizers) n = 7	LY2216684 (CYP2C19 Extensive Metabolizers) n = 7
Value	749 (37)	698 (21)

Population analysed: Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis. Participants who vomited within twice the median time to maximum observed drug concentration (tmax) following dosing of LY2216684 were excluded from the analysis.

Primary outcome: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)

Time frame: Predose up to 120 hours post administration of LY2216684. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	LY2216684 (CYP2C19 Poor Metabolizers) n = 7	LY2216684 (CYP2C19 Extensive Metabolizers) n = 7
Value	54.7 (28)	54.8 (25)

Primary outcome: Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)

Time frame: Predose up to 120 hours post administration of LY2216684. Median (Full Range). Unit: hours

Measure	LY2216684 (CYP2C19 Poor Metabolizers) n = 7	LY2216684 (CYP2C19 Extensive Metabolizers) n = 7
Value	2.00 (1.00 to 3.02)	2.00 (1.92 to 5.00)

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 (CYP2C19 Extensive and Poor Metabolizers)	0 of 18 (0%)	10 of 18 (55.6%)	Not reported
Quinidine (CYP2C19 Poor Metabolizers)	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
LY2216684 + Quinidine (CYP2C19 Poor Metabolizers)	0 of 7 (0%)	3 of 7 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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 Quinidine in people with Depressive Disorder, Major, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 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 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 26 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 Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM) (time frame: Predose up to 120 hours post administration of LY2216684). 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 NCT01460381.

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 Oct 2018.