A Study of Brain Receptor Occupancy in Healthy Subjects

Lilly

Status and phase: Completed; Phase 1

Conditions: Alcohol Dependence

Treatments: Drug: opioid receptor kappa antagonist

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232439

12511

I2Z-MC-LAFC (Other Identifier)

Details and patient eligibility

About

To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

opioid receptor kappa antagonist

Experimental group

Treatment:

Drug: opioid receptor kappa antagonist