Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-05212384

Study type

Interventional

Funder types

Industry

Identifiers

NCT02142920

B2151006

Details and patient eligibility

About

The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects between the ages of 30- 65 years vasectomised or >40 with no desire to father children in the near future (12 months), 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 35 kg/m2; and a total body weight >50 kg (110 lbs).
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Subjects agree to use an adequate method of contraception

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).
A positive urine drug screen or history of drug or alcohol abuse in the past 2 years.