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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00781482
• Other study ID #: 07-104-SEPR
• Status: Withdrawn
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: February 25, 2016

Study information

• Verified date: February 2016
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 show that we can use positron emission tomography images to measure the binding of these medications to the receptors.

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 for three separate positron emission tomography (PET) scans. Over the course of the three study visits, each subject will receive eszopiclone (Lunesta), zolpidem (ambien) and a placebo in random order.

After each medication or placebo dose, a PET scan will be done using a [11-C] flumazenil (Romazicon). The flumazenil will help us measure the binding of the study medications to chemical receptors called GABA receptors in certain parts of the brain.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• eszopiclone, zolpidem, placebo
In random order, each subject will receive one study drug per visit over three visits. Visits will occur about 1 week apart. Each subject will eventually receive eszopiclone 3 mg., zolpidem 10 mg., and a placebo. PET scans will be done 1-2 hours after each dose.

Locations

Country	Name	City	State
United States	Kettering Medical Center	Kettering	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Kettering Health Network	Abiant, Inc., Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will measure GABA receptor binding by PET imageing after each dose of study medication or placebo.		PET scans will occur within 1-2 hours after study drug or placebo administration. Visits will occur approximately 1 week apart. . Subjects will have visits scheduled over approximately 6 weeks, including screening, scanning visits, and follow-up.	No