Healthy Volunteers
Conditions
Brief summary
To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.
Interventions
DRUGPF-06273588
Intravenous, 50 microgram, single dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
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 measurements, 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).
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. * History of regular alcohol consumption exceeding 21 drinks/week for males.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with Adverse Events as a measure of Safety and tolerability. | 3 days |
| Pharmacokinetics : peak plasma concentration | 3 days |
| Pharmacokinetics : time of peak plasma concentration | 3 days |
| Pharmacokinetics : area under plasma concentration-time curve | 3 days |
| Pharmacokinetics : Terminal plasma half life | 3 days |
| Pharmacokinetics : Plasma Clearance | 3 days |
| Pharmacokinetics : plasma volume of distribution | 3 days |
| Pharmacokinetics : oral bioavailability | 3 days |
Countries
United Kingdom
Outcome results
None listed