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Single Dose Study To Study The Absorption, Metabolism And Excretion Of PF-04991532

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ClinicalTrials.gov Identifier: NCT01469481
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of [14C]PF-04991532 in healthy adult male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04991532 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
Study Start Date : November 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: 1 Drug: PF-04991532
a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)

Primary Outcome Measures :
  1. Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered. [ Time Frame: 0-168 hrs ]
  2. Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces. [ Time Frame: 0-168 hrs ]
  3. radioactivity AUC [ Time Frame: 0-168 hrs ]
  4. plasma PF-04991532 AUC [ Time Frame: 0-168 hrs ]
  5. radioactivity Cmax [ Time Frame: 0-168 hrs ]
  6. plasma PF-04991532 Cmax [ Time Frame: 0-168 hrs ]
  7. plasma PF-04991532 Tmax [ Time Frame: 0-168 hrs ]
  8. radioactivity Tmax [ Time Frame: 0-168 hrs ]
  9. plasma PF-04991532 t1/2 [ Time Frame: 0-168 hrs ]
  10. radioactivity t1/2 [ Time Frame: 0-168 hrs ]

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

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 measurement, 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).
  • An informed consent document signed and dated by the subject.

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) or clinical findings at Screening.
  • History of irregular bowel movements (eg, irritable bowel syndrome or frequent episodes of diarrhea or constipation).
  • Any condition possibly affecting drug absorption (eg, appendectomy, gastrectomy).

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): NCT01469481

United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01469481     History of Changes
Other Study ID Numbers: B2611007
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
diabetes mellitus

Additional relevant MeSH terms:
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs