Healthy
Conditions
Keywords
Healthy Volunteers
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).
Interventions
DRUGPF-05212384
Single 89 mg Dose via 30 minute IV infusion
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0.5 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| 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. |
Countries
United Kingdom
Outcome results
None listed