Depressive Disorder, MajorPhase 1NCT01389752

A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects

A Phase 1 study testing LY2216684 and Activated Charcoal 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 involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal. The study will evaluate the effect of charcoal on the absorption of LY2216684. 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 Activated Charcoal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Sep 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 subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of the study drug
Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control 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] >40 mIU/mL [milli-international-units/milliliter])
Have a body weight >50 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

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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 (sitting position)

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product 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, 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

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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 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), and stable doses (at least 1 month) of oral contraceptive therapy
Have donated blood of more than 500 mL (milliliter) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to dosing in each period until discharge in each period (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 each period until discharge in each period
Subjects 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 7 days prior to enrollment or are unwilling to avoid them during the study
Subjects 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.
Dallas, Texas, 75247

Other trials in United States

About this study

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

The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal.

The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.

Conditions: Depressive Disorder, Major
Being tested: LY2216684, Activated Charcoal
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
Activated CharcoalDrug
Administered orally

Study groups in NCT01389752
Study group	Role	What they receive
LY2216684 without Charcoal, then with Charcoal	Experimental	Period 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days. Receives: Drug: LY2216684; Drug: Activated Charcoal
LY2216684 with Charcoal, then without Charcoal	Experimental	Period 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days. Receives: Drug: LY2216684; Drug: Activated Charcoal

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
The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Measured: Predose, up to 72 hours after administration of study drug
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684
The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Measured: Predose, up to 72 hours after administration of study drug
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
The tmax for LY2216684 was assessed.
Measured: Predose, 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.

Jul 2011Sep 2011

First posted8 Jul 2011 (estimated)
Study startJul 2011
Primary completionSep 2011
Study completionSep 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01389752
Sponsor's protocol ID: 12612
Other IDs: H9P-EW-LNCU
Status last verified: Dec 2018
First submitted: 6 Jul 2011
Last updated: 4 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?

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 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Activated Charcoal on the Pharmacokinetics of LY2216684 in Healthy Subjects
ClinicalTrials.gov ID: NCT01389752
Acronym / sponsor ID: 12612
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 8 Jul 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.

The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LY2216684 without Charcoal, then with Charcoal	Experimental	Drug: LY2216684, Drug: Activated CharcoalPeriod 1: Single 18-mg (milligram) (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg (gram/kilogram) of Activated Charcoal. Periods will be separated by a minimum of 7 days.
LY2216684 with Charcoal, then without Charcoal	Experimental	Drug: LY2216684, Drug: Activated CharcoalPeriod 1: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered with single oral dose of 1 g/kg of Activated Charcoal. Period 2: Single 18-mg (two 9-mg tablets) oral dose of LY2216684 administered without Activated Charcoal. Periods will be separated by a minimum of 7 days.

Who may qualify

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

Key inclusion criteria (9 listed)

Are overtly healthy, as determined by medical history and physical examination
Have a body weight >50 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
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Key exclusion criteria (19 listed)

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product 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, 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 with Charcoal, then without Charcoal, LY2216684 without Charcoal, then with Charcoal
Activated CharcoalAdministered orally	Drug	LY2216684 with Charcoal, then without Charcoal, LY2216684 without Charcoal, then with Charcoal

Primary outcome

Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Time frame: Predose, up to 72 hours after administration of study drug
The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684
Time frame: Predose, up to 72 hours after administration of study drug
The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Time frame: Predose, up to 72 hours after administration of study drug
The tmax for LY2216684 was assessed.

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 Without Charcoal, Then With Charcoal	11	11
LY2216684 With Charcoal, Then Without Charcoal	11	9

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

Time frame: Predose, up to 72 hours after administration of study drug. Geometric least squares mean (90% Confidence Interval). Unit: nanogram*hour/milliliter (ng*h/mL)

Measure	LY2216684 in Combination With Activated Charcoal n = 17	LY2216684 Alone n = 19
Value	509 (454 to 571)	786 (701 to 881)

LY2216684 in Combination With Activated Charcoal vs LY2216684 Alone: Ratio of Geometric Least Squares Means: 0.65 (90% CI 0.61 to 0.68), Mixed Models Analysis

Population analysed: All participants who were randomized, for whom AUC0-∞ data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.

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

Time frame: Predose, up to 72 hours after administration of study drug. Geometric least squares mean (90% Confidence Interval). Unit: nanogram/milliliter (ng/mL)

Measure	LY2216684 in Combination With Activated Charcoal n = 17	LY2216684 Alone n = 19
Value	54.06 (49.16 to 59.44)	59.84 (54.55 to 65.63)

LY2216684 in Combination With Activated Charcoal vs LY2216684 Alone: Ratio of Geometric Least Squares Means: 0.90 (90% CI 0.83 to 0.98), Mixed Models Analysis

Population analysed: All participants who were randomized, for whom Cmax data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.

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

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

Measure	LY2216684 in Combination With Activated Charcoal n = 17	LY2216684 Alone n = 17
Value	2.00 (0.92 to 3.00)	2.03 (2.00 to 5.00)

LY2216684 in Combination With Activated Charcoal vs LY2216684 Alone: Median Difference (Final Values): -0.55 (90% CI -1.04 to -0.50), p = 0.0010, Wilcoxon (Mann-Whitney)

Population analysed: All participants who were randomized, for whom tmax data were available, and who were not excluded due to vomiting within twice the median tmax of LY2216684.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2216684 in Combination With Activated Charcoal	0 of 22 (0%)	9 of 22 (40.9%)	Not reported
LY2216684 Alone	0 of 20 (0%)	7 of 20 (35%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 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 Activated Charcoal 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 9 inclusion and 19 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 4 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 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 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 NCT01389752.

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 4 Jan 2019; AzTrials last refreshed its copy on 2 Nov 2026.