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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01469481
First received: October 28, 2011
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Healthy
Drug: PF-04991532
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • radioactivity AUC [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • plasma PF-04991532 AUC [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • radioactivity Cmax [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • plasma PF-04991532 Cmax [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • plasma PF-04991532 Tmax [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • radioactivity Tmax [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • plasma PF-04991532 t1/2 [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]
  • radioactivity t1/2 [ Time Frame: 0-168 hrs ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-04991532
a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)

  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 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).
  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: NCT01469481

Locations
United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98418
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: NCT01469481     History of Changes
Other Study ID Numbers: B2611007
Study First Received: October 28, 2011
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
diabetes mellitus
ADME

ClinicalTrials.gov processed this record on July 22, 2014