A Study of Brain Receptor Occupancy in Healthy Subjects

Alcohol Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232439
• Other study ID #: 12511
• Secondary ID: I2Z-MC-LAFC
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2010
• Last updated: May 5, 2011
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)		Baseline, after single dose of study drug	No
Secondary	Pharmacokinetics, area under the curve (AUC)		Days 1 and 2	No
Secondary	Number of participants with clinically significant effects		Baseline to study completion	No
Secondary	Pharmacokinetics, concentration maximum (Cmax)		Days 1 and 2	No