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A Phase I, Healthy Volunteer Positron Emission Tomography Study

NCT00730990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-04

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

DRUG

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.

DRUG

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.

DRUG

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).

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730990 on ClinicalTrials.gov