Major Depressive DisorderPhase 1NCT01263236

A Study of LY2940094 in Major Depressive Disorder

A Phase 1 study testing LY2940094 in people with Major Depressive Disorder, run by BlackThorn Therapeutics, Inc. at 1 site in Canada.

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 investigate the safety and tolerability of ascending single and multiple oral doses of LY2940094 in healthy male subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: LY2940094
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteCanada
Study dates: Dec 2010to Sep 2011
Phase: Phase 1
Are there results?: None posted in the registry

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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males of any ethnic origin.
Have a body mass index (BMI) between 19.0 and 30.0 kilogram/square meter (kg/m²), inclusive.
Must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations.
Have a calculated creatinine clearance of greater than 70 milliliter/minute (mL/min).
Have venous access sufficient to allow blood sampling as per the protocol.
Will have given their written informed consent to participate in the study and to abide by the study restrictions.

Who cannot join

Male subjects who are not, or whose partners are not willing to use appropriate contraception from the time of the first dose until 3 months after the final dosing occasion.
Have received any prescribed systemic or topical medication within 14 days of the first dose administration
Have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
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 donated or lost 50 to 499 milliliter (mL) of whole blood within 30 days, or more than 499 milliliter (mL) whole blood within 56 days preceding first dose administration.

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Have a significant history of drug allergy as determined by the Investigator.
Have any clinically significant allergic disease (excluding non-active hay fever), or any known allergy to LY2940094 or excipients as determined by the Investigator.
Have a semi-reclined blood pressure and pulse rate higher than 130/90 millimeters of mercury (mmHg) and 100 beats per minute (bpm), respectively, or lower than 90/50 millimeters of mercury (mmHg) and 40 beats per minute (bpm), respectively.
Consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse/dependence as determined by the Investigator.
Have a positive urine drug screen or alcohol breath test result that indicates substance abuse at screening or at admission to any treatment period.
Smoke more than 10 cigarettes or the equivalent in tobacco per day and willing to avoid smoking for durations of at least 10 hours.
With, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
Have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
Have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for human immunodeficiency virus (HIV) antibodies.
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risk of participating in the study. In addition, subjects with the following findings will be excluded:
Confirmed Bazett's corrected QT (QTcB) interval greater than 450 millisecond (msec) in 2 of 3 electrocardiograms (ECGs).
Bundle branch blocks and other conduction abnormalities (including 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolffe-Parkinson-White Syndrome, defined as PR less than 110 milliseconds (msec),confirmed by a repeat electrocardiogram [ECG]) other than mild first-degree atrioventricular block (AV) block.
Irregular rhythms other than sinus arrhythmia or occasional rare supraventricular ectopic beats.
History of unexplained syncope.
Family history of unexplained syncope or sudden death due to long QT syndrome.
T wave configurations are not of adequate quality for assessing QTc intervals.
Have previously completed or been withdrawn from this study.
Taking any excluded medications that cannot be discontinued at Screening.
Have a personal or family history of recurrent seizures or complicated febrile seizures.
Have a history of significant brain trauma.
Have epileptiform activity on baseline electroencephalogram (EEG).
The following exclusion criteria apply only to those subjects enrolling in the part of the study involving lumbar puncture (LP) procedures
Have abnormalities in lumbar spine as determined by the investigator
Have a history of clinically significant back pain and/or back injury
Have evidence or history of significant active bleeding or coagulation disorder
Have an allergy to lidocaine (Xylocaine®) or its derivatives
Have medical or surgical conditions in which LP is contraindicated The following exclusion criterion applies only to those subjects enrolling in the part of the study involving alcohol interaction Have an intolerance or allergy toward alcohol (symptoms may include nausea, flushed face, vomiting, or hypotension) or who, in the opinion of the investigator, may not be able to tolerate 0.8 gram per kilogram (g/kg) alcohol

Trial locations and contacts

1 site in 1 country.

Canada1 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.
Toronto, Ontario, M5V 2T3

Other trials in Canada

About this study

Official title: A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of LY2940094 in Healthy Male Subjects

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of LY2940094 in healthy male subjects.

Conditions: Major Depressive Disorder
Being tested: LY2940094, Placebo
Keywords: Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2940094Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT01263236
Study group	Role	What they receive
LY2940094 - single dose	Experimental	Single oral dose of 2-800 milligram (mg) LY2940094 Receives: Drug: LY2940094
LY2940094 - multiple dose	Experimental	Daily oral dose of 2-200 mg LY2940094 for 14 days Receives: Drug: LY2940094
Placebo	Experimental	Single oral dose or daily oral dose for 14 days Receives: Drug: Placebo

What is being measured

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

Number of participants with clinically significant effects
Measured: Baseline to study completion

Secondary outcomes (4)

Pharmacokinetics of LY2940094, maximal concentration (Cmax)- single dose
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose
Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- single dose
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose
Pharmacokinetics of LY2940094, maximal concentration (Cmax) - multiple dose
Measured: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7
Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- multiple dose
Measured: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7

Timeline

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

Dec 2010Sep 2011

First posted20 Dec 2010 (estimated)
Study startDec 2010
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263236
Sponsor's protocol ID: 14095
Other IDs: I5J-MC-NOAA
Status last verified: Feb 2017
First submitted: 16 Dec 2010
Last updated: 3 Feb 2017
Results posted: No
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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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of LY2940094 in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01263236
Acronym / sponsor ID: 14095
Conditions: Major Depressive Disorder
Keywords: Depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: BlackThorn Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of LY2940094 in healthy male subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
LY2940094 - single dose	Experimental	Drug: LY2940094Single oral dose of 2-800 milligram (mg) LY2940094
LY2940094 - multiple dose	Experimental	Drug: LY2940094Daily oral dose of 2-200 mg LY2940094 for 14 days
Placebo	Experimental	Drug: PlaceboSingle oral dose or daily oral dose for 14 days

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Males of any ethnic origin.
Have a body mass index (BMI) between 19.0 and 30.0 kilogram/square meter (kg/m²), inclusive.
Must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations.
Have a calculated creatinine clearance of greater than 70 milliliter/minute (mL/min).
Have venous access sufficient to allow blood sampling as per the protocol.

Key exclusion criteria (33 listed)

Male subjects who are not, or whose partners are not willing to use appropriate contraception from the time of the first dose until 3 months after the final dosing occasion.
Have received any prescribed systemic or topical medication within 14 days of the first dose administration
Have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
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.

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
LY2940094Administered orally	Drug	LY2940094 - multiple dose, LY2940094 - single dose
PlaceboAdministered orally	Drug	Placebo

Primary outcome

Number of participants with clinically significant effects
Time frame: Baseline to study completion

4 secondary outcomes

Pharmacokinetics of LY2940094, maximal concentration (Cmax)- single dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose
Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- single dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose
Pharmacokinetics of LY2940094, maximal concentration (Cmax) - multiple dose
Time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7
Pharmacokinetics of LY2940094, area under the concentration-time curve (AUC)- multiple dose
Time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours postdose on day 1, predose on days 2-6, predose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours postdose on day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.

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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 LY2940094 in people with Major Depressive Disorder, run by BlackThorn Therapeutics, Inc. at 1 site in Canada.

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 6 inclusion and 33 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 3 Feb 2017. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with clinically significant effects (time frame: Baseline to study completion). 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 NCT01263236.

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 3 Feb 2017.