Depressive Disorder, MajorPhase 1NCT01460407

A Study to Evaluate the Effect of Clarithromycin on LY2216684

A Phase 1 study testing LY2216684 and Clarithromycin 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

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Trial summary

The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of LY2216684 in healthy participants. Side effects will be documented. There will be 2 study periods (5 and 9 days) and follow up will occur at least 7 days after the last dose. 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 Clarithromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Dec 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:
o 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:
o 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 study drug; or 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) >40 milli-international units per milliliter (mIU/mL)]
Have a body weight >50 kilograms (kg)

Show all 12Show fewer

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
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 both cytochrome P450 (CYP)2D6 and CYP2C19 extensive metabolizer (EM) phenotypes 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 clarithromycin, related compounds, or any components of the formulation
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history of/or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation

Show all 20Show fewer

Have a documented or suspected history of glaucoma
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 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, hormone replacement therapy including thyroid replacement (stable dose for at least 1 month)
Use of known inhibitors and/or inducers of CY2D6, CYP2C19, and/or CYP3A 30 days prior to enrollment or are unwilling to avoid them during the study (except for use of clarithromycin)
Have donated blood of more than 500 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 oz (ounces) 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 or foods of comparable caffeine content) per day, on a habitual basis, or are unwilling to stop caffeine consumption from 48 hours prior to dosing in Period 1 until discharge
Participants unwilling to adhere to the smoking restrictions of the Clinical Research Unit (CRU) while a resident of the CRU
Have consumed grapefruit or grapefruit-containing products, starfruit, or pomegranates 30 days prior to enrollment or are unwilling to avoid them during the study
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, 32117

Other trials in United States

About this study

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

Conditions: Depressive Disorder, Major
Being tested: LY2216684, Clarithromycin
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
ClarithromycinDrug
Administered orally

Study groups in NCT01460407
Study group	Role	What they receive
LY2216684 + Clarithromycin	Experimental	Participants will receive a single 18-mg oral dose of LY2216684 on Days 1 and 10. Clarithromycin (500 mg) will be administered twice a day (BID) on Days 6 through 13. Receives: Drug: LY2216684; Drug: Clarithromycin

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 (AUC0-∞) of LY2216684
AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.
Measured: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
Cmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Measured: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Tmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Measured: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)

Timeline

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

Oct 2011Dec 2011

First posted26 Oct 2011 (estimated)
Study startOct 2011
Primary completionDec 2011
Study completionDec 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: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01460407
Sponsor's protocol ID: 14401
Other IDs: H9P-EW-LNEB
Status last verified: Mar 2018
First submitted: 24 Oct 2011
Last updated: 19 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 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Clarithromycin on the Pharmacokinetics of LY2216684 in Healthy Subjects
ClinicalTrials.gov ID: NCT01460407
Acronym / sponsor ID: 14401
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 26 Oct 2011 (estimated)
Results: Posted 19 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 + Clarithromycin	Experimental	Drug: LY2216684, Drug: ClarithromycinParticipants will receive a single 18-mg oral dose of LY2216684 on Days 1 and 10. Clarithromycin (500 mg) will be administered twice a day (BID) on Days 6 through 13.

Who may qualify

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

Key inclusion criteria (12 listed)

Are overtly healthy as determined by medical history and physical examination
Male participants:
o 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:
o 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 study drug; or 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) >40 milli-international units per milliliter (mIU/mL)]

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 clarithromycin, related compounds, or any components of the formulation
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history of/or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders 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 + Clarithromycin
ClarithromycinAdministered orally	Drug	LY2216684 + Clarithromycin

Primary outcome

Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Cmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Tmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.

Results and safety

Results posted to the registry on 19 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	14	14
LY2216684 and Clarithromycin	0	0

Primary outcome: Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684

Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10). Geometric mean (90% Confidence Interval). Unit: nanogram*hours per milliliter (ng*h/mL)

Measure	LY2216684 n = 14	LY2216684 and Clarithromycin n = 14
Value	582 (498 to 681)	746 (638 to 873)

LY2216684 vs LY2216684 and Clarithromycin: Ratio of geometric LS mean: 1.28 (90% CI 1.16 to 1.42)

Population analysed: Full Analysis Set: Participants who received at least 1 dose of LY2216684.

Primary outcome: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684

Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10). Geometric mean (90% Confidence Interval). Unit: nanograms per milliliter (ng/mL)

Measure	LY2216684 n = 14	LY2216684 and Clarithromycin n = 14
Value	52.58 (46.38 to 59.61)	63.55 (56.06 to 72.04)

LY2216684 vs LY2216684 and Clarithromycin: Ratio of geometric LS mean: 1.21 (90% CI 1.12 to 1.31)

Population analysed: Full Analysis Set: Participants who received at least 1 dose of LY2216684.

Primary outcome: Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684

Time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10). Median (90% Confidence Interval). Unit: hours (h)

Measure	LY2216684 n = 14	LY2216684 and Clarithromycin n = 14
Value	2.00 (1.00 to 5.00)	2.00 (2.00 to 4.00)

LY2216684 vs LY2216684 and Clarithromycin: Median of paired differences: 0.00 (90% CI -0.50 to 0.50), p = 0.7656, Wilcoxon (Mann-Whitney)

Population analysed: Full Analysis Set: Participants who received at least 1 dose of LY2216684.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2216684	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
LY2216684 and Clarithromycin	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Clarithromycin	0 of 14 (0%)	4 of 14 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 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 Clarithromycin 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 12 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 19 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 19 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 (AUC0-∞) of LY2216684 (time frame: Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)). 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 NCT01460407.

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 19 Oct 2018.