A Phase I, Healthy Volunteer Positron Emission Tomography Study

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00730990
First received: August 5, 2008
Last updated: December 2, 2008
Last verified: December 2008
  Purpose

The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at the H3 receptor after a single oral dose of PF 03654746.


Condition Intervention Phase
Healthy
Other: Positron Emission tomography
Other: PET Scan with PF-03654746
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: A8801007 A Phase I, Healthy Volunteer Qualification Of Ligand [C 11] PF 04621053 And Randomized Determination Of H3 Receptor Occupancy Of PF 03654746, Using PET

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall H3 Receptor Occupancy of PF 03654746. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binding potential (BP) of [C-11]PF 04621053. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Relationship between serum PF 03654746 concentration and H3 RO (IC50). [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • H3 RO of PF 03654746 at regions of interest in man [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
This arm will have no active treatment.
Other: Positron Emission tomography
Positron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
Experimental: Cohort 2 Other: PET Scan with PF-03654746
If none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
Other: PET Scan with PF-03654746
If none of the data from the previous interventions are informative, then: 3) an additional 3 patients will receive 2 scans on Day 1 and 1 scan on Day 2 following three different doses of PF-0365476. Doses will be determined based upon the outcomes of the previous interventions.
Other: PET Scan with PF-03654746

Part 2 of the study will have 3 possible interventions:

1) 3 subjects in Cohort 2 will receive 2 scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746 (0.5 mg, 1.5 mg, 4 mg).


Detailed Description:

Additional Study Purpose Details: To validate PET ligand which will be used to determine receptor occupancy and to determine receptor occupancy of PF-0367456

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects 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).
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). A BMI at the lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • History of febrile illness within 5 days prior to the first dose.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen at Screening or Day 0.
  • History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  • Positive cotinine screen at Screening or Day 0.
  • Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication (excluding [C-11]PF-04621053).
  • 12-lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
  • Chronic (every day) use of a histamine (H1, H2) inhibitor(s) within 3 months before screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730990

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Pfizer
Yale University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00730990     History of Changes
Other Study ID Numbers: A8801007
Study First Received: August 5, 2008
Last Updated: December 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Positron Emission Tomography study in healthy volunteers for ligand qualification and receptor occupancy determination.

ClinicalTrials.gov processed this record on September 16, 2014