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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-04991532

Study type

Interventional

Funder types

Industry

Identifiers

NCT01469481
B2611007

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

1
Experimental group
Treatment:
Drug: PF-04991532

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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