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OpenTrials
Completed

NCT Number: NCT01173757

To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (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
  • Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire

Treatment and study plan

PF-04995274

Drug

Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1

Primary outcomes

  1. Exposure response of overall 5HT4 receptor occupancy of PF-04995274

    Time frame: up to 3 days

  2. 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain

    Time frame: up to 3 days

Secondary outcomes

  1. Adverse events

    Time frame: up to 3 days

  2. change from baseline in vital signs

    Time frame: up to 3 days

  3. Singlet ECG post-dose

    Time frame: up to 3 days

  4. Clinical safety laboratory endpoints

    Time frame: up to 3 days

  5. Clinical examinations

    Time frame: up to 3 days

  6. Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma

    Time frame: up to 3 days

  7. Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma

    Time frame: up to 3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 2, 2010
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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