A Study of Brain Receptor Occupancy in Healthy Subjects

NCT01232439 — Phase 1, Completed, 13 participants, Eli Lilly and Company

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01232439
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	13 (Actual)
Sponsor	Eli Lilly and Company (Industry)
Conditions	Alcohol Dependence
Interventions	opioid receptor kappa antagonist (Drug)
Dates	start 2010-12-01, primary completion 2011-04-01, completion 2011-04-01, first posted 2010-11-02, last updated 2011-05-09
Locations	1 site in United States

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
opioid receptor kappa antagonist	Experimental	Drug: opioid receptor kappa antagonist

opioid receptor kappa antagonist (Drug), also known as LY2456302: Starting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg

+Outcome measures

Primary outcomes

Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET) [Baseline, after single dose of study drug]

Secondary outcomes

Pharmacokinetics, area under the curve (AUC) [Days 1 and 2]
Number of participants with clinically significant effects [Baseline to study completion]
Pharmacokinetics, concentration maximum (Cmax) [Days 1 and 2]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
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

+Investigators

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), Study director, Eli Lilly and Company