ABOUT THIS STUDY
- Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, 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).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- 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).
- Have or have had clinically significant infections within the past 3 months prior to
the first dose of investigational product (eg, those requiring hospitalization or
parenteral antibiotics, or as judged by the Investigator), evidence of any infection
within the past 7 days prior to the first dose of investigational product, herpes
simplex within 12 weeks or history of disseminated herpes simplex infection,
symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B
surface antibody (HepBsAb) finding as a result of participant vaccination is
- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON tuberculosis (TB) Gold test.
- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of investigational
product used in this study (whichever is longer).
- Female participants who are pregnant or wish to become pregnant; breastfeeding
- Males/Females of childbearing potential who are unwilling or unable to use a highly
effective method of contraception as outlined in this protocol for the duration of the
study and for at least 28 days after the last dose of investigational product.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.
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