A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C]PF-00299804 in Healthy Male Volunteers
- 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
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- 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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males (1 drink =
5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard
liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products within 3 months of screening or a
positive urine cotinine test at Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
- 12 lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the
ECG should be repeated two more times and the average of the three QTc values should
be used to determine the subject's eligibility.
- Subjects enrolled in a previous radionucleotide study or who have received
radiotherapy within 12 months prior to screening or such that total radioactivity
would exceed acceptable dosimetry.
- Subjects whose occupation requires exposure to radiation or monitoring of radiation
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of study medication.
Herbal supplements must be discontinued 28 days prior to the first dose of study
medication. As an exception, acetaminophen/paracetamol may be used at doses of 1
g/day. Limited use of non prescription medications that are not believed to affect
subject safety or the overall results of the study may be permitted on a case-by-case
basis following approval by the sponsor.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subject is the investigator or a sub investigator, research assistant, pharmacist,
study coordinator, other staff, or a relative of study personnel directly involved
with the conduct of the study.
- Subjects who are believed to be unable and/or unlikely to comprehend and follow the
- Subjects with a history of irregular bowel movements eg, regular episodes of diarrhea
or constipation, irritable bowel syndrome (IBS) or lactose intolerance.
- Unwilling or unable to comply with the Lifestyle guidelines described in this
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.