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

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ClinicalTrials.gov Identifier: NCT01408355
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-06273588 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

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
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



Primary Outcome Measures :
  1. The number of participants with Adverse Events as a measure of Safety and tolerability. [ Time Frame: 3 days ]
  2. Pharmacokinetics : peak plasma concentration [ Time Frame: 3 days ]
  3. Pharmacokinetics : time of peak plasma concentration [ Time Frame: 3 days ]
  4. Pharmacokinetics : area under plasma concentration-time curve [ Time Frame: 3 days ]
  5. Pharmacokinetics : Terminal plasma half life [ Time Frame: 3 days ]
  6. Pharmacokinetics : Plasma Clearance [ Time Frame: 3 days ]
  7. Pharmacokinetics : plasma volume of distribution [ Time Frame: 3 days ]
  8. Pharmacokinetics : oral bioavailability [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01408355     History of Changes
Other Study ID Numbers: B4381001
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 2011