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A Study of Brain Receptor Occupancy in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01232439
First received: October 20, 2010
Last updated: May 5, 2011
Last verified: May 2011
History of Changes

October 20, 2010
May 5, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01232439 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Days 1 and 2 ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics, concentration maximum (Cmax) [ Time Frame: Days 1 and 2 ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01232439
12511, I2Z-MC-LAFC
No
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