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
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Drug: opioid receptor kappa antagonist
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232439

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01232439     History of Changes
Other Study ID Numbers: 12511, I2Z-MC-LAFC
Study First Received: October 20, 2010
Last Updated: May 5, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014