Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers
- Registration Number
- NCT02142920
- Lead Sponsor
- Pfizer
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C] PF 05212384 PF-05212384 Receive PF-05212384 89 mg Dose
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) 0.5 hours Time to Reach Maximum Observed Plasma Concentration (Tmax) 0.5 hours
- Secondary Outcome Measures
Name Time Method Systemic Clearance (CL) 9 days CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Area under the Concentration-Time Curve (AUC) 9 days AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 9 Days Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2) 9 days Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Volume of Distribution at Steady State (Vss) 9 days Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Ruddington Fields, Nottingham, United Kingdom