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

NCT01528241 | Completed Phase 1

• 1 other identifier: CABP688A2102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depression

Keywords

ABP688; Tracer; Depression

Outcome Measures

Primary Outcomes (2)

• Binding of [11C] ABP688 to mGlu5 receptors

  Binding of \[11C\]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes

  Day 1

• Blood levels of [11C] ABP688

  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.

  Day 1, up to 60 minutes

Secondary Outcomes (1)

• Difference in [11C]ABP688 binding to mGlu5 receptors

  Day 1

Study Arms (1)

ABP688

EXPERIMENTAL

Elderly MDD patients and demography matched healthy volunteer

Drug: ABP688

Interventions

ABP688 DRUG

Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.

ABP688

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

New York, New York, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Location

Related Links

• Results for CABP688A2102 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Depression

Interventions

3-(6-methylpyridin-2-ylethynyl)cyclohex-2-enone-O-methyloxime

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 7, 2012
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 8, 2020

Record last verified: 2012-02

Locations

US (2)