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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01408355
First received: June 30, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: PF-06273588
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The number of participants with Adverse Events as a measure of Safety and tolerability. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics : peak plasma concentration [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : time of peak plasma concentration [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : area under plasma concentration-time curve [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : Terminal plasma half life [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : Plasma Clearance [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : plasma volume of distribution [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics : oral bioavailability [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 50 microgram PF-06273588 oral
Subjects will receive a single oral microdose of PF-06273588 in period two
Drug: PF-06273588
Oral solution, 50 microgram, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408355

Locations
United Kingdom
Pfizer Investigational Site
Ruddington Fields, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01408355     History of Changes
Other Study ID Numbers: B4381001
Study First Received: June 30, 2011
Last Updated: September 8, 2011
Health Authority: United Kingdom: Medicine and Healthcare products Regulatory Agency

ClinicalTrials.gov processed this record on July 23, 2014