Alcohol DependencePhase 1NCT01232439
A Study of Brain Receptor Occupancy in Healthy Subjects
A Phase 1 study testing opioid receptor kappa antagonist in people with Alcohol Dependence, run by Eli Lilly and Company at 1 site in United States.
Trial summary
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- opioid receptor kappa antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female
- Have clinical laboratory tests within normal reference ranges
- Have arterial and venous access sufficient to allow blood sampling
Who cannot join
- Currently enrolled in, or discontinued within the last 30 days from a clinical trial
- History of severe allergies or multiple adverse drug reactions
- Have an abnormal ECG at screening visit
- Have abnormal sitting blood pressure
- Have an increased risk of seizures
- Current suicidal ideation
Show all 13Show fewer
- Positive test for HIV, hepatitis C, or hepatitis B
- Women who are breast feeding
- Smoke more than 10 cigarettes per day, or equivalent
- Drink more than 5 cups of coffee per day, or equivalent
- Have a history of head injury
- Unable to undergo a MRI
- Suffer from claustrophobia
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.
New Haven, Connecticut, 06519
About this study
Official title: Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
- Conditions
- Alcohol Dependence
- Being tested
- opioid receptor kappa antagonist
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid receptor kappa antagonistDrug
Also called LY2456302
Starting dose of 2 mg, administered orally, once.
The potential dose range for this study is 0.2 mg to 30 mg
| Study group | Role | What they receive |
|---|---|---|
| opioid receptor kappa antagonist | Experimental | Not described Receives: Drug: opioid receptor kappa antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Measured: Baseline, after single dose of study drug
Secondary outcomes (3)
Pharmacokinetics, area under the curve (AUC)
Measured: Days 1 and 2
Number of participants with clinically significant effects
Measured: Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Measured: Days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT01232439
- Sponsor's protocol ID
- 12511
- Other IDs
- I2Z-MC-LAFC
- Status last verified
- May 2011
- First submitted
- 20 Oct 2010
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01232439
- Acronym / sponsor ID
- 12511
- Conditions
- Alcohol Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Nov 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.
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| opioid receptor kappa antagonist | Experimental | Drug: opioid receptor kappa antagonist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female
- Have clinical laboratory tests within normal reference ranges
- Have arterial and venous access sufficient to allow blood sampling
Key exclusion criteria (13 listed)
- Currently enrolled in, or discontinued within the last 30 days from a clinical trial
- History of severe allergies or multiple adverse drug reactions
- Have an abnormal ECG at screening visit
- Have abnormal sitting blood pressure
- Have an increased risk of seizures
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 |
|---|---|---|
| opioid receptor kappa antagonistAlso: LY2456302Starting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg | Drug | opioid receptor kappa antagonist |
Primary outcome
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Time frame: Baseline, after single dose of study drug
3 secondary outcomes
Pharmacokinetics, area under the curve (AUC)
Time frame: Days 1 and 2
Number of participants with clinically significant effects
Time frame: Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Time frame: Days 1 and 2
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 9 May 2011.
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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 opioid receptor kappa antagonist in people with Alcohol Dependence, 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 3 inclusion and 13 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 9 May 2011. 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?
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 in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) (time frame: Baseline, after single dose of study drug). 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 9 May 2011.