Healthy VolunteersPhase 1NCT01524237
A Study of LY2979165 and LY2140023 in Healthy Volunteers
A Phase 1 study testing LY2979165, LY2140023 and Ketamine in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United Kingdom.
Trial summary
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants. Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be completed before starting Part B. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY2979165, LY2140023 and Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2012to Jul 2013
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination
- agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study drug
- if female partners are of child-bearing potential, agree to use 2 effective methods of birth control during the study and for a period of 3 months after the final dose of study drug
- one (1) of these methods must be a male or female condom used in conjunction with spermicidal gel, foam, cream, film or suppository
- the other method can be any of the following:
- diaphragm or cervical vault cap used in conjunction with spermicidal gel, foam, cream, film, or suppository
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- male partner sterilization
- true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)
- placement of an effective intrauterine device (IUD) (Consideration should be given to the type of device or system being used, as there are higher failure rates quoted for certain types)
- established use of oral, injected, or implanted hormonal methods of contraception
- have a body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive, and weigh 50.0 to 100.0 kg, at the time of screening
- 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 and administration of intravenous (IV) ketamine 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 ethical review board (ERB) governing the site
Who cannot join
- are currently enrolled in, have completed or discontinued within the last 90 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 to LY2979165, LY2140023, ketamine, related compounds or any components of the formulations
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2979165 or LY2140023
- 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 or have a PR interval greater than 200 msec, or QTc interval greater than 450 msec
- have an abnormal resting, supine blood pressure (BP), defined as systolic blood pressure (BP) greater than 150 mm Hg or diastolic BP greater than 85 mm Hg, or a heart rate (HR) outside the range of 40 to 85 beats per minute (bpm), inclusive
- have a history or presence of 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
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- have a history of or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- show evidence of significant active neuropsychiatric disease, suicidal risk (including suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale [C-SSRS]) or have a first degree relative with a history of psychosis
- show evidence of human immunodeficiency virus (HIV) infection and/or positive 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
- have used or intend to use over-the-counter or prescription medication within 7 days prior to dosing. Herbal supplements must be discontinued 28 days prior to the first dose of trial medication. At the discretion of the investigator a shorter drug free or discontinuation period may be acceptable depending on the precise drugs/supplements taken. As an exception, paracetamol or acetaminophen may be used at doses of up to 1 g/day
- have donated blood of more than 500 mL within the last month
- have an average weekly alcohol intake that exceeds 28 units per week, or are unwilling to stop alcohol consumption for 48 hours prior to dosing until the completion of each study period and restrict consumption to no more than 3 units per day for the duration of the study (1 unit = 190 mL of beer; 87.5 mL of wine; 25 mL of distilled spirits)
- use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or unable/unwilling to abide by the clinical research unit (CRU) smoking restrictions from admission to the CRU until discharge for each study period
- consume caffeine equivalent to more than 6 cups of coffee per day, on a habitual basis, or are unable to abide by the study restrictions for caffeine/xanthine use (that is, refrain from consuming caffeine/xanthine-containing drinks and foods (such as coffee, tea, cola, and chocolate) from admission to the CRU until discharge for each study period
- in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
- Have increased risk of seizures as evidenced by a history of more than 1 seizure (except childhood febrile seizure), history of electroencephalogram (EEG) with epileptiform activity, history of stroke; surgery to the cerebral cortex; or head trauma with loss of consciousness
- Additional criteria for Part B only:
- History of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session
- Fulfillment of any of the magnetic resonance imaging (MRI) contraindications on the standard radiography screening questionnaire (for example, history of surgery involving metal implants)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
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.
London, Greater London, SE5 8AF
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.
London, UK, SE 1 1YR
About this study
Official title: Biomarker Study: Impact of Single Doses of LY2979165 and LY2140023 on the Ketamine-Challenge Pharmacological MRI Assay in Healthy Male Subjects
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants.
Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be completed before starting Part B.
Read more
Part B of this study will investigate whether different dose levels of LY2979165 or LY2140023, when administered before ketamine, result in changes to the images on a brain scan seen with ketamine alone. Brain imaging is currently used for a number of reasons including understanding where in the brain medicines have their effects. Ketamine is an anesthetic used in this study to activate particular regions of the brain.
The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg with matching dummy drug (placebo) for each dose.
The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.
Screening is required within 28 days prior to the start of the study and follow up 7-14 days after the last dose of study drug. The study will last up to 8-weeks for an individual participant.
- Conditions
- Healthy Volunteers
- Being tested
- LY2979165, LY2140023, Placebo, Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2979165Drug
Capsules administered orally
LY2140023Drug
Tablets administered orally
PlaceboOther
Administered orally
KetamineOther
Administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| 10 mg LY2140023 + ketamine | Experimental | Single oral dose of 10 mg LY2140023 followed by intravenous (IV) ketamine during one of the crossover periods Receives: Drug: LY2140023; Other: Ketamine |
| 20 mg LY2979165 + ketamine | Experimental | Single oral dose of 20 mg LY2979165 followed by IV ketamine during one of the crossover periods Receives: Drug: LY2979165; Other: Ketamine |
| 40 mg LY2140023 + ketamine | Experimental | Single oral dose of 40 mg LY2140023 followed by IV ketamine during one of the crossover periods Receives: Drug: LY2140023; Other: Ketamine |
| 60 mg LY2979165 + ketamine | Experimental | Single oral dose of 60 mg LY2979165 followed by IV ketamine during one of the crossover periods Receives: Drug: LY2979165; Other: Ketamine |
| 160 mg LY2140023 + ketamine | Experimental | Single oral dose of 160 mg of LY2140023 followed by IV ketamine during one of the crossover periods Receives: Drug: LY2140023; Other: Ketamine |
| Placebo capsules + ketamine | Placebo comparator | Single oral dose of placebo capsules followed by IV ketamine during one of the crossover periods Receives: Other: Placebo; Other: Ketamine |
| Placebo tablets + ketamine | Placebo comparator | Single oral dose of placebo tablets followed by IV ketamine during one of the crossover periods Receives: Other: Placebo; Other: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Measured: Part A: Day 1 through 3
Part B: Changes in hemoglobin oxygenation in the brain during ketamine infusion
Measured: Part B: Day 1
Secondary outcomes (4)
Pharmacokinetics: Area under the concentration curve (AUC) of LY2979165, LY2140023, and active metabolites
Measured: Up to Day 3
Pharmacokinetics: Maximum concentration (Cmax) of LY2979165, LY2140023, and active metabolites
Measured: Up to Day 3
Pharmacokinetics: Area under the concentration curve (AUC) of ketamine and nor-ketamine
Measured: Up to Day 3
Relationship between active compounds' exposure (e.g. AUC) and hemoglobin oxygenation in the brain
Measured: Part B: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524237
- Sponsor's protocol ID
- 13882
- Other IDs
- I4S-EW-HHCC
- Status last verified
- Jul 2013
- First submitted
- 30 Jan 2012
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study: Impact of Single Doses of LY2979165 and LY2140023 on the Ketamine-Challenge Pharmacological MRI Assay in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01524237
- Acronym / sponsor ID
- 13882
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Feb 2012 (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.
This study will be comprised of 2 parts, Part A and Part B, both in healthy male participants.
Part A of the study will investigate the safety of intravenous (IV) ketamine administration after single oral doses of LY2979165 (capsules) or LY2140023 (tablets). Part A will be completed before starting Part B.
Part B of this study will investigate whether different dose levels of LY2979165 or LY2140023, when administered before ketamine, result in changes to the images on a brain scan seen with ketamine alone. Brain imaging is currently used for a number of reasons including understanding where in the brain medicines have their effects. Ketamine is an anesthetic used in this study to activate particular regions of the brain.
The single oral doses of LY2979165 to be used in both parts of the study are 20 and 60 mg with matching dummy drug (placebo) for each dose.
The doses for LY2140023 are 10, 40, and 160 mg with matching placebo for each dose.
Screening is required within 28 days prior to the start of the study and follow up 7-14 days after the last dose of study drug. The study will last up to 8-weeks for an individual participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 10 mg LY2140023 + ketamine | Experimental | Drug: LY2140023, Other: KetamineSingle oral dose of 10 mg LY2140023 followed by intravenous (IV) ketamine during one of the crossover periods |
| 20 mg LY2979165 + ketamine | Experimental | Drug: LY2979165, Other: KetamineSingle oral dose of 20 mg LY2979165 followed by IV ketamine during one of the crossover periods |
| 40 mg LY2140023 + ketamine | Experimental | Drug: LY2140023, Other: KetamineSingle oral dose of 40 mg LY2140023 followed by IV ketamine during one of the crossover periods |
| 60 mg LY2979165 + ketamine | Experimental | Drug: LY2979165, Other: KetamineSingle oral dose of 60 mg LY2979165 followed by IV ketamine during one of the crossover periods |
| 160 mg LY2140023 + ketamine | Experimental | Drug: LY2140023, Other: KetamineSingle oral dose of 160 mg of LY2140023 followed by IV ketamine during one of the crossover periods |
| Placebo capsules + ketamine | Placebo comparator | Other: Placebo, Other: KetamineSingle oral dose of placebo capsules followed by IV ketamine during one of the crossover periods |
| Placebo tablets + ketamine | Placebo comparator | Other: Placebo, Other: KetamineSingle oral dose of placebo tablets followed by IV ketamine during one of the crossover periods |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination
- agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study drug
- if female partners are of child-bearing potential, agree to use 2 effective methods of birth control during the study and for a period of 3 months after the final dose of study drug
- have a body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive, and weigh 50.0 to 100.0 kg, at the time of screening
- 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 (21 listed)
- are currently enrolled in, have completed or discontinued within the last 90 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 to LY2979165, LY2140023, ketamine, related compounds or any components of the formulations
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2979165 or LY2140023
- 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 or have a PR interval greater than 200 msec, or QTc interval greater than 450 msec
- have an abnormal resting, supine blood pressure (BP), defined as systolic blood pressure (BP) greater than 150 mm Hg or diastolic BP greater than 85 mm Hg, or a heart rate (HR) outside the range of 40 to 85 beats per minute (bpm), inclusive
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 |
|---|---|---|
| LY2979165Capsules administered orally | Drug | 20 mg LY2979165 + ketamine, 60 mg LY2979165 + ketamine |
| LY2140023Tablets administered orally | Drug | 10 mg LY2140023 + ketamine, 160 mg LY2140023 + ketamine, 40 mg LY2140023 + ketamine |
| PlaceboAdministered orally | Other | Placebo capsules + ketamine, Placebo tablets + ketamine |
| KetamineAdministered intravenously (IV) | Other | 10 mg LY2140023 + ketamine, 160 mg LY2140023 + ketamine, 20 mg LY2979165 + ketamine, 40 mg LY2140023 + ketamine, 60 mg LY2979165 + ketamine, Placebo capsules + ketamine, Placebo tablets + ketamine |
Primary outcome
Part A: Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Time frame: Part A: Day 1 through 3
Part B: Changes in hemoglobin oxygenation in the brain during ketamine infusion
Time frame: Part B: Day 1
4 secondary outcomes
Pharmacokinetics: Area under the concentration curve (AUC) of LY2979165, LY2140023, and active metabolites
Time frame: Up to Day 3
Pharmacokinetics: Maximum concentration (Cmax) of LY2979165, LY2140023, and active metabolites
Time frame: Up to Day 3
Pharmacokinetics: Area under the concentration curve (AUC) of ketamine and nor-ketamine
Time frame: Up to Day 3
Relationship between active compounds' exposure (e.g. AUC) and hemoglobin oxygenation in the brain
Time frame: Part B: Up to 3 days
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 2 Aug 2013.
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Screening Protocol
Pain
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2979165, LY2140023 and Ketamine in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United Kingdom.
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 15 inclusion and 21 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Part A: Number of participants with one or more drug related adverse events (AEs) or any serious AEs (time frame: Part A: Day 1 through 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2013.