- Male and female participants who are overtly healthy as determined by medical
evaluation including a detailed medical history, complete physical examination,
laboratory tests, and cardiovascular tests.
- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
- Female participants who are of child bearing potential must not be intending to become
pregnant, currently pregnant, or lactating.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
infection; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis
B core antibody (HepBcAb), or hepatitis C virus antibody (HCVAb).
- Other acute or chronic medical or psychiatric condition including recent (within the
past year).
- Evidence or history of clinically significant dermatological condition (eg, atopic
dermatitis or psoriasis) or visible rash present during physical examination.
- Clinically relevant history of lactic acidosis.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half lives (whichever is longer) prior to the first dose of
investigational product.
- A positive urine drug test.
- Selected laboratory abnormalities.
- History of regular alcohol consumption exceeding 14 drinks/week for female
participants or 21 drinks/week for male participants (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 before screening.
- Known relevant history of elevated liver function tests (LFTs).
- History of tuberculosis (TB) (active or latent)
- Any history of chronic infections, any history of recurrent infections, any history of
latent infections, or any acute infection within 2 weeks of baseline.
- History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent
localized dermatomal herpes zoster.