Clinical trial NCT00939887: A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bipolar Disorder
Depression
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall kappa opioid receptor occupancy of PF 04455242.
timeFrame: Study Day 1 and 2
Secondary outcomes:
measure: Binding potential (BP) of [11C] PF 04767135.
timeFrame: Study Day 1 and 2
measure: Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man.
timeFrame: Study Day 1 and 2
measure: Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50).
timeFrame: Study Day 1 and 2
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: