A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)

Depression Clinical Trial

Official title:

A Phase 1, Healthy Volunteer Qualification Of Ligand [11C] PF-04767135 And Randomized Determination Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00939887
• Other study ID #: B1071003
• Status: Terminated
• Phase: Phase 1
• First received: July 13, 2009
• Last updated: February 4, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• A positive urine drug screen at Screening or Day 0.

• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.

• Use of tobacco- or nicotine-containing products within 3 months of screening.

• Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication (excluding [11C]PF 04767135).

• 12 lead ECG demonstrating QTc >450 msec at Screening.

• Pregnant or nursing females; females of childbearing potential.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression

Intervention

Drug:
• PF-04455242
Single dose of up to 30 mg PF-04455242, delivered in capsule.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall kappa opioid receptor occupancy of PF 04455242.		Study Day 1 and 2	No
Secondary	Binding potential (BP) of [11C] PF 04767135.		Study Day 1 and 2	No
Secondary	Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man.		Study Day 1 and 2	No
Secondary	Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50).		Study Day 1 and 2	No

External Links

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