Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)
NCT ID: NCT01528241
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2008-08-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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ABP688
Elderly MDD patients and demography matched healthy volunteer
ABP688
Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
Interventions
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ABP688
Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
Eligibility Criteria
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Inclusion Criteria
* Subjects in good health
At screening:
* oral body temperature between 35-37.5C
* systolic blood pressure: 90-140 mm Hg
* diastolic blood pressure: 50-90 mm Hg
* pulse rate: 40-90 bpm
* Female subjects of child bearing potential must have been using a double-barrier local contraception
* Postmenopausal women must have had no menstrual bleeding
* Subjects must have weighed at least 50 kg
* All subjects must provide informed consent
* All subjects must have been able to communicate well with investigator
Specific to Major depression disorder (MDD)
Patients had to show following level of symptomatology:
* HAM-D (17-item scale) \> 16
* CGI \> 4 (moderately ill)
Exclusion Criteria
\- Presence and/or history of clinically significant major neurological or psychiatric disorder
Specific criteria for MDD patients:
* Presence and/or history of a clinically significant major neurological or psychiatric disorder other than MDD or generalized anxiety disorder
* Axis I co-morbidity was excluded except anxiety spectrum disorders
Criteria for both:
* Smokers
* Pregnancy
* Subjects with history of or symptoms/complaints consistent with mild cognitive impairment
* Use of any psychotropic prescription drugs
* Coffee consumers more than 6 cups/day
* Participation in any clinical investigation
* Donation or loss of 400 mL or more of blood
* Significant illness within 2 weeks prior to dosing
* A known hypersensitivity to study drug
* MRI scan that showed evidence of stroke
* Any surgical or medical condition which might have significantly altered distribution
* Clinical evidence of any abnormal lab value
* History of immunodeficiency disease
* Positive Hepatitis B surface antigen
* Presence of contraindications to PET scan investigations- Presence of contraindications to MRI investigations
* Evidence from an Allen test of incomplete communication
* History of drug or alcohol abuse
* Current use of anticonvulsant
* Significant radiation exposure
55 Years
80 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Results for CABP688A2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CABP688A2102
Identifier Type: -
Identifier Source: org_study_id