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Completed

NCT Number: NCT01469481

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

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.

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Key information

Conditions

Healthy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-04991532

Drug

a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2011
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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