Back to resultsA Study of Brain Receptor Occupancy in Healthy Subjects
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
opioid receptor kappa antagonist
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female
- Have clinical laboratory tests within normal reference ranges
- Have arterial and venous access sufficient to allow blood sampling
Exclusion Criteria:
- 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
- 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
opioid receptor kappa antagonist
Arm Description
Outcomes
Primary Outcome Measures
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Secondary Outcome Measures
Pharmacokinetics, area under the curve (AUC)
Number of participants with clinically significant effects
Pharmacokinetics, concentration maximum (Cmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01232439
Brief Title
A Study of Brain Receptor Occupancy in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
opioid receptor kappa antagonist
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
opioid receptor kappa antagonist
Other Intervention Name(s)
LY2456302
Intervention Description
Starting dose of 2 mg, administered orally, once.
The potential dose range for this study is 0.2 mg to 30 mg
Primary Outcome Measure Information:
Title
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Time Frame
Baseline, after single dose of study drug
Secondary Outcome Measure Information:
Title
Pharmacokinetics, area under the curve (AUC)
Time Frame
Days 1 and 2
Title
Number of participants with clinically significant effects
Time Frame
Baseline to study completion
Title
Pharmacokinetics, concentration maximum (Cmax)
Time Frame
Days 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female
Have clinical laboratory tests within normal reference ranges
Have arterial and venous access sufficient to allow blood sampling
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
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