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

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: ABP688

• Registration Number: NCT01528241
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-07
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABP688	ABP688	Elderly MDD patients and demography matched healthy volunteer

Primary Outcome Measures

Name	Time	Method
Binding of [11C] ABP688 to mGlu5 receptors	Day 1	Binding of \[11C\]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes
Blood levels of [11C] ABP688	Day 1, up to 60 minutes	Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of \[11C\] ABP688. Specific times are recorded at the clinical site.

Secondary Outcome Measures

Name	Time	Method
Difference in [11C]ABP688 binding to mGlu5 receptors	Day 1	Using data generated as described above, data will be analyzed to determine if there are difference in binding between healthy volunteers and patients.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Pittsburgh, Pennsylvania, United States