Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to characterize the regional distribution of [11C] ABP688 in brain by positron emission tomography (PET).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female subjects 55-80 (inclusive)

• 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:

Specific criteria for healthy volunteers:

• 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

Other protocol-defined inclusion/exclusion criteria may apply.