A Study To Observe Safety And Blood Concentrations Of PF-06412562 During And Following The Oral Administration Of Multiple Doses Of PF-06412562 In Healthy Adult Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/3/2014 |
Start Date: | November 2013 |
End Date: | March 2014 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in
healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
Inclusion Criteria:
- Healthy female subjects of non-childbearing potential and/or 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
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).
- 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.
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