A Study of Brain Receptor Occupancy in Healthy Subjects

May 5, 2011 updated by: Eli Lilly and Company

Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: opioid receptor kappa antagonist
Drug: 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

Other Names:
  • LY2456302

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics, area under the curve (AUC)
Time Frame: Days 1 and 2
Days 1 and 2
Number of participants with clinically significant effects
Time Frame: Baseline to study completion
Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Time Frame: Days 1 and 2
Days 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12511
  • I2Z-MC-LAFC (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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