DepressionPhase 1NCT01404091

A Study of Nociceptin/Orphanin FQ Peptide Receptor Occupancy in Healthy Subjects

A Phase 1 study testing LY2940094 in people with Depression, 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.

Trial summary

The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide (NOP) receptor occupancy (RO) in healthy 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: Depression
What is being tested?: LY2940094
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteCanada
Study dates: Jul 2011to Nov 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

Have a body mass index between 19.0 and 30.0 kilogram square meter (kg/m²), inclusive, weight less than 125.0 kilogram (kg), and physical dimensions which appear small enough to fit into the magnetic resonance imaging (MRI) and positron emission tomography scanners (PET)
Must be in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Have venous and arterial access sufficient to allow blood sampling
Are nonsmokers for at least 3 months prior to Screening, according to self report (meaning zero cigarettes smoked)
Have a calculated creatinine clearance of greater than (>)70 milliliters per minute (mL/min) at Screening
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
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 (condom with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after dosing
Have received any prescribed systemic or topical medication within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
Have used any nonprescribed 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 unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
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 mL of whole blood within 30 days, or more than 499 mL whole blood within 56 days preceding first dose administration

Show all 34Show fewer

Have a significant history of drug allergy as determined by the Investigator
Have any clinically significant allergic disease (excluding nonactive hay fever), or any known allergy to LY2940094 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, respectively, or lower than 90/50 mmHg and 40 beats per minute, respectively
Consume more than 14 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse/dependence as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
Have a positive urine drug screen or alcohol breath test result that indicates substance abuse at screening or at admission to any treatment period
With, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator
With, or with a history of, any psychiatric illness as assessed with the Symptom Checklist (SCL-90R)
Have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
Have serum hepatitis (B or C), or who are carriers of the hepatitis B surface antigen 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 interval (QTcB) greater than (>) 450 milliseconds (msec)
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 interval less than (<) 110 msec, confirmed by a repeat ECG other than mild first-degree 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 (cardiac output) syndrome
T wave configurations are not of adequate quality for assessing corrected QTc intervals
Have previously completed or been withdrawn from this study or any other study investigating LY2940094
Subjects who, in the opinion of the Investigator, should not participate in the study
Taking any excluded medications that cannot be discontinued at admission to the clinical research unit (CRU)
Have a personal or family history of recurrent seizures or complicated febrile seizures
Have a history of a significant brain condition/trauma
Indicates presence of suicidal ideation by answering "yes" to either of the first two questions on the baseline version of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening
Have any contraindication to magnetic resonance imaging (MRI) , such as implanted or embedded metal objects or fragments in the head or body that would present a risk during the magnetic resonance imaging (MRI) scanning procedure, or have worked with ferrous metal either as a vocation or hobby (for example, as a sheet metal worker, welder or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
Have had exposure to ionizing radiation in a research study that, in combination with the study tracer, would result in a cumulative exposure that exceeds recommended exposure limits of greater than (>) 20 millisieverts (mSv) in 1 year
Suffer from claustrophobia and would be unable to tolerate the confined spaces of magnetic resonance imaging (MRI) or positron emission tomography (PET) camera as evidenced by claustrophobia screening
Without a minimum of 37 inches (112 centimeters [cm] ) from the top of the head to the end of the wrist so as to allow reasonable access to the wrist to take a blood sample during the positron emission tomography (PET) scan
Have a significant history of hypersensitivity reactions to gelatin capsules.
Any other condition which, in the opinion of the investigator, would preclude participation in the study

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

Other trials in Canada

About this study

Official title: Assessment of Nociceptin/Orphanin FQ Peptide Receptor Occupancy After Single Oral Doses of LY2940094 as Measured by Positron Emission Tomography With the Radioligand LY2959530 in Healthy Subjects

The purpose of this trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide (NOP) receptor occupancy (RO) in healthy subjects.

Conditions: Depression
Being tested: LY2940094
Medical subject headings: Depression

What participants receive

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

LY2940094Drug
Administered orally

Study groups in NCT01404091
Study group	Role	What they receive
Cohort 1: 40 milligram (mg) LY2940094	Experimental	40 mg LY2940094 was administered orally, one time only (it was originally expected that 100 mg LY2940094 would be administered). If the receptor occupancy (RO) for a given dose is lower than 50%, (time to maximum concentration [tmax] or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. Receives: Drug: LY2940094
Cohort 2: 10 mg LY2940094	Experimental	The dose levels for subjects in Cohort 2 will be defined based on the results of the receptor occupancy (RO) data of previous cohort and the ongoing review of safety data. This dose was determined to be 10 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. Receives: Drug: LY2940094
Cohort 3: 4 mg LY2940094	Experimental	The dose levels for subjects in Cohort 3 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 4 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. Receives: Drug: LY2940094
Cohort 4: 20 mg LY2940094	Experimental	The dose levels for subjects in Cohort 4 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 20 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. Receives: Drug: LY2940094

What is being measured

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

Change from Baseline in Nociceptin/Orphanin FQ Peptide (NOP) Receptor Occupancy at Day 2
Measured: Baseline, Day 2 (occurs 1-4 weeks after baseline)

Secondary outcomes (2)

Pharmacokinetics: maximal plasma concentration (Cmax) of LY2940094
Measured: Predose, up to 29 hours post dose
Pharmacokinetics: area under the concentration- time curve (AUC) of LY2940094
Measured: Predose, up to 29 hours post dose

Timeline

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

Jul 2011Nov 2011

First posted27 Jul 2011 (estimated)
Study startJul 2011
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01404091
Sponsor's protocol ID: 14333
Other IDs: I5J-MC-NOAB
Status last verified: Feb 2017
First submitted: 26 Jul 2011
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: Assessment of Nociceptin/Orphanin FQ Peptide Receptor Occupancy After Single Oral Doses of LY2940094 as Measured by Positron Emission Tomography With the Radioligand LY2959530 in Healthy Subjects
ClinicalTrials.gov ID: NCT01404091
Acronym / sponsor ID: 14333
Conditions: Depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: BlackThorn Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 27 Jul 2011 (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 trial is to conduct an assessment of brain nociceptin/orphanin FQ peptide (NOP) receptor occupancy (RO) in healthy subjects.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1: 40 milligram (mg) LY2940094	Experimental	Drug: LY294009440 mg LY2940094 was administered orally, one time only (it was originally expected that 100 mg LY2940094 would be administered). If the receptor occupancy (RO) for a given dose is lower than 50%, (time to maximum concentration [tmax] or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 2: 10 mg LY2940094	Experimental	Drug: LY2940094The dose levels for subjects in Cohort 2 will be defined based on the results of the receptor occupancy (RO) data of previous cohort and the ongoing review of safety data. This dose was determined to be 10 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 3: 4 mg LY2940094	Experimental	Drug: LY2940094The dose levels for subjects in Cohort 3 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 4 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.
Cohort 4: 20 mg LY2940094	Experimental	Drug: LY2940094The dose levels for subjects in Cohort 4 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 20 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts.

Who may qualify

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

Key inclusion criteria (7 listed)

Have a body mass index between 19.0 and 30.0 kilogram square meter (kg/m²), inclusive, weight less than 125.0 kilogram (kg), and physical dimensions which appear small enough to fit into the magnetic resonance imaging (MRI) and positron emission tomography scanners (PET)
Must be in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Have venous and arterial access sufficient to allow blood sampling
Are nonsmokers for at least 3 months prior to Screening, according to self report (meaning zero cigarettes smoked)
Have a calculated creatinine clearance of greater than (>)70 milliliters per minute (mL/min) at Screening

Key exclusion criteria (34 listed)

Male subjects who are not, or whose partners are not willing to use appropriate contraception (condom with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after dosing
Have received any prescribed systemic or topical medication within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
Have used any nonprescribed 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 unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety
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	Cohort 1: 40 milligram (mg) LY2940094, Cohort 2: 10 mg LY2940094, Cohort 3: 4 mg LY2940094, Cohort 4: 20 mg LY2940094

Primary outcome

Change from Baseline in Nociceptin/Orphanin FQ Peptide (NOP) Receptor Occupancy at Day 2
Time frame: Baseline, Day 2 (occurs 1-4 weeks after baseline)

2 secondary outcomes

Pharmacokinetics: maximal plasma concentration (Cmax) of LY2940094
Time frame: Predose, up to 29 hours post dose
Pharmacokinetics: area under the concentration- time curve (AUC) of LY2940094
Time frame: Predose, up to 29 hours post dose

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 Depression, 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 7 inclusion and 34 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?

Change from Baseline in Nociceptin/Orphanin FQ Peptide (NOP) Receptor Occupancy at Day 2 (time frame: Baseline, Day 2 (occurs 1-4 weeks after baseline)). 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 NCT01404091.

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.