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

October 20, 2010
November 2, 2010
May 9, 2011
December 2010
April 2011   (Final data collection date for primary outcome measure)
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) [ Time Frame: Baseline, after single dose of study drug ]
Same as current
Complete list of historical versions of study NCT01232439 on Archive Site
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Days 1 and 2 ]
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ]
  • Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: Days 1 and 2 ]
Same as current
Not Provided
Not Provided
A Study of Brain Receptor Occupancy in Healthy Subjects
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Alcohol Dependence
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
Experimental: opioid receptor kappa antagonist
Intervention: Drug: opioid receptor kappa antagonist
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
I2Z-MC-LAFC ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP