Alcohol Dependence
Conditions
Brief summary
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
Interventions
DRUGopioid receptor kappa antagonist
Starting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) | Baseline, after single dose of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, area under the curve (AUC) | Days 1 and 2 |
| Number of participants with clinically significant effects | Baseline to study completion |
| Pharmacokinetics, concentration maximum (Cmax) | Days 1 and 2 |
Countries
United States
Outcome results
None listed