Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem

Status:

WITHDRAWN

Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem

Lead Sponsor:

Kettering Health Network

Collaborating Sponsors:

Abiant, Inc.

Sumitomo Pharma America, Inc.

Conditions:

Healthy

Eligibility:

MALE

18-35 years

Phase:

PHASE4

Brief Summary

This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in the brain. We want to s...

Detailed Description

We will enroll 4 normal, healthy, adult male volunteers who will undergo screening tests (labs, EKGs, medical history, physical exam, and MRI of the brain) for safety. If eligible, they will return fo...

Eligibility Criteria

Inclusion

Healthy Males age 18 to 35 inclusive
Body Mass Index 18 to 30
Willing to adhere to prohibitions and restrictions specified in protocol
Must give informed consent.

Exclusion

Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening.
Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening
Significant history of or current significant medical illness.
Significant history of or current psychiatric or neurological illness or sleep apnea.
Participation in another research study involving exposure to ionizing radiation within the last 12 months.
Any clinically significant MR abnormality which may be relevant to the study.
Metal implants which are relevant for MR or PET procedures or data.
History of epilepsy or fits or unexplained blackouts.
Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies.
Positive urine screen for drugs of abuse.
Positive alcohol screen.
Known or suspected alcoholism or drug addiction even if currently abstaining
Drinks on average more than 8 cups of coffee, tea, cocoa, or cola per day.
Smoking cigarettes within 3 months prior to study drug administration.
Clinically significant acute illnes within 7 days of study drug administration.
Claustrophobia.
Donation of 1 or more units of blood (approximately 450ml), or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
Have received an experimental drug or used an experimental medical device within 90 days of planned start of treatment with drugs for this study.
Use of any prescription or over the counter medication, or herbal medication (not including non-steroidal anti-inflammatory drugs) within 2 weeks of the first PET scan. Of particular concern would be GABA-ergic compounds and CYP3A4 inhibitors. Exclusion should also be considered if the subject has taken a drug with a long half-life (or of any metabolite) even if taken outside the two week time window. However, the subject can still be enrolled if, in the opinion of the investigator, such medication taken in that timeframe will not interfere with the results of the study.
Psychological or emotional problems that would render the informed consent invalid or limit the ability of the subject to comply with the study requirements.
Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00781482

Last Update

February 26 2016

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