A Study of Brain Receptor Occupancy in Healthy Subjects

NCT ID: NCT01232439

Last Updated: 2011-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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opioid receptor kappa antagonist

Group Type EXPERIMENTAL

opioid receptor kappa antagonist

Intervention Type DRUG

Starting dose of 2 mg, administered orally, once.

The potential dose range for this study is 0.2 mg to 30 mg

Interventions

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opioid 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

Intervention Type DRUG

Other Intervention Names

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LY2456302

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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I2Z-MC-LAFC

Identifier Type: OTHER

Identifier Source: secondary_id

12511

Identifier Type: -

Identifier Source: org_study_id

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