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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01469481

Enrollment

Registered

2011-11-10

Start date

2011-11-30

Completion date

2011-11-30

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

diabetes mellitus, ADME

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.

Interventions

DRUGPF-04991532

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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).

Design outcomes

Primary

Measure	Time frame
Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.	0-168 hrs
Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.	0-168 hrs
radioactivity AUC	0-168 hrs
plasma PF-04991532 AUC	0-168 hrs
radioactivity Cmax	0-168 hrs
plasma PF-04991532 Cmax	0-168 hrs
plasma PF-04991532 Tmax	0-168 hrs
radioactivity Tmax	0-168 hrs
plasma PF-04991532 t1/2	0-168 hrs
radioactivity t1/2	0-168 hrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026