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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00939887
Pfizer
Terminated
A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)

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A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
A Phase 1, Healthy Volunteer Qualification Of Ligand [11C] PF-04767135 And Randomized Determination Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
  • Bipolar Disorder
  • Depression
Drug: PF-04455242
Single dose of up to 30 mg PF-04455242, delivered in capsule.
Experimental: Treatment
Intervention: Drug: PF-04455242
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00939887
B1071003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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