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

NCT00939887 | Terminated Phase 1

• 1 other identifier: B1071003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Bipolar Disorder; Depression

Outcome Measures

Primary Outcomes (1)

• Overall kappa opioid receptor occupancy of PF 04455242.

  Study Day 1 and 2

Secondary Outcomes (3)

• Binding potential (BP) of [11C] PF 04767135.

  Study Day 1 and 2

• Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man.

  Study Day 1 and 2

• Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50).

  Study Day 1 and 2

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: PF-04455242

Interventions

PF-04455242 DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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).
• lead ECG demonstrating QTc \>450 msec at Screening.
• Pregnant or nursing females; females of childbearing potential.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06519, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 15, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 8, 2010

Record last verified: 2010-02

Locations

US (3)