A Study of Brain Receptor Occupancy in Healthy Subjects

Phase 1

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: opioid receptor kappa antagonist

• Registration Number: NCT01232439
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-05
• Last Update Posted: 2011-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Healthy male or female
• Have clinical laboratory tests within normal reference ranges
• Have arterial and venous access sufficient to allow blood sampling

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
opioid receptor kappa antagonist	opioid receptor kappa antagonist	-

Primary Outcome Measures

Name	Time	Method
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)	Baseline, after single dose of study drug

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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, United States