A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects

To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-06273588; Drug: PF-06273588

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington Fields, Nottingham, United Kingdom, NG11 6JS
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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 measurements, 12-lead ECG and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 microgram PF-06273588 intravenous; Subjects will receive a single intravenous microdose of PF-06273588 in period one	Drug: PF-06273588; Intravenous, 50 microgram, single dose; Drug: PF-06273588; Oral solution, 50 microgram, single dose
Experimental: 50 microgram PF-06273588 oral; Subjects will receive a single oral microdose of PF-06273588 in period two	Drug: PF-06273588; Intravenous, 50 microgram, single dose; Drug: PF-06273588; Oral solution, 50 microgram, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants with Adverse Events as a measure of Safety and tolerability.	3 days
Pharmacokinetics : peak plasma concentration	3 days
Pharmacokinetics : time of peak plasma concentration	3 days
Pharmacokinetics : area under plasma concentration-time curve	3 days
Pharmacokinetics : Terminal plasma half life	3 days
Pharmacokinetics : Plasma Clearance	3 days
Pharmacokinetics : plasma volume of distribution	3 days
Pharmacokinetics : oral bioavailability	3 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): September 9, 2011
• Last Update Submitted That Met QC Criteria: September 8, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: B4381001