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

NCT01253655 | Completed Phase 1

• 1 other identifier: B1961009
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  up to 4 days

Secondary Outcomes (14)

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

  continuous, up to 4 days

• Change from baseline in orthostatic blood pressure

  Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose

• Change from baseline in supine blood pressure

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

• Change from baseline in Singlet ECG

  Baseline and 72 hrs post-dose

• 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).

  Baseline and 72 hrs post-dose

Study Arms (1)

PF-05212365

EXPERIMENTAL

Drug: PF-05212365

Interventions

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.

Also known as: SAM-531

PF-05212365

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Yale University: collaborator

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

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

SAM-531

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 28, 2011

Record last verified: 2011-04

Locations

US (3)