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Completed

NCT Number: NCT01253655

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-05212365 in healthy volunteers

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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-05212365

Drug

Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.

Other names: SAM-531

Primary outcomes

  1. Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects

    Time frame: up to 4 days

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: continuous, up to 4 days

  2. Change from baseline in orthostatic blood pressure

    Time frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose

  3. Change from baseline in supine blood pressure

    Time frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose

  4. Change from baseline in Singlet ECG

    Time frame: Baseline and 72 hrs post-dose

  5. Clinically relevant levels of standard hemotology (e.g. Hemoglobin, Hematocrit RBC count), chemistry (e.g. BUN, Creatinine, fasting Glucose), and urinalysis (e.g. pH Glucose, Protein).

    Time frame: Baseline and 72 hrs post-dose

  6. Abnormal findings from standard physical examination

    Time frame: Baseline and 72 hrs post-dose

  7. Maximum concentration (Cmax) for PF-05212365 in plasma

    Time frame: up to 4 days

  8. Time at Cmax (Tmax) for PF-05212365 in plasma

    Time frame: up to 4 days

  9. Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma

    Time frame: up to 4 days

  10. Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212365 in plasma

    Time frame: 2-4 hrs post-dose

  11. Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212365 in plasma

    Time frame: 48-50 hrs post dose

  12. Change from baseline in orthostatic pulse rate

    Time frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose

  13. Change from baseline in supine pulse rate

    Time frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose

  14. Abnormal findings from standard neurological examination

    Time frame: Baseline and 72 hrs post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Yale University

Registry information

Official study title

A Phase 1, Open-Label Study To Evaluate 5-HT6 Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]PF-04171252 Following Single Oral Dose Administration Of PF-05212365 (SAM-531) In Healthy Subjects

Acronym: 3193A1-1103

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 3, 2010
Registry last updated
Apr 28, 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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