Skip to main content
OpenTrials
Completed

NCT Number: NCT01232439

A Study of Brain Receptor Occupancy in Healthy Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioid receptor kappa antagonist

Drug

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

Primary outcomes

  1. Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)

    Time frame: Baseline, after single dose of study drug

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2010
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.