NCT00730990

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2008

Typical duration for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

August 5, 2008

Last Update Submit

February 28, 2019

Conditions

Healthy

Keywords

Positron Emission Tomography study in healthy volunteers for ligand qualification and receptor occupancy determination.

Outcome Measures

Primary Outcomes (1)

  • Overall H3 Receptor Occupancy of PF 03654746.

    48 hours

Secondary Outcomes (3)

  • Binding potential (BP) of [C-11]PF 04621053.

    48 hours

  • Relationship between serum PF 03654746 concentration and H3 RO (IC50).

    48 hours

  • H3 RO of PF 03654746 at regions of interest in man

    48 hours

Study Arms (2)

Cohort 1

EXPERIMENTAL

This arm will have no active treatment.

Other: Positron Emission tomography

Cohort 2

EXPERIMENTAL
Drug: PET Scan with PF-03654746

Interventions

Positron Emission tomographyOTHER

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.

Cohort 1
PET Scan with PF-03654746DRUG

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.

Cohort 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

New Haven, Connecticut, 06511, 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

MeSH Terms

Interventions

Magnetic Resonance SpectroscopyN-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

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
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 4, 2019

Record last verified: 2019-02

Locations

US(3)