A Study of Brain Receptor Occupancy in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232439
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : May 9, 2011
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: opioid receptor kappa antagonist Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects
Study Start Date : December 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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 Name: LY2456302

Primary Outcome Measures :
  1. Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) [ Time Frame: Baseline, after single dose of study drug ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232439

United States, Connecticut
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, 06519
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company

Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT01232439     History of Changes
Other Study ID Numbers: 12511
I2Z-MC-LAFC ( Other Identifier: Eli Lilly and Company )
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: May 9, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents