1. Male and female (of non-childbearing potential) participants must be 18 to 55 years of
age, inclusive, at the time of signing the informed consent document (ICD).
2. Male and female participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, including blood pressure
(BP) and pulse rate measurement, temperature, standard 12-lead ECG, telemetry and
laboratory tests.
3. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures. Note
that participants enrolling as Japanese must have 4 biological Japanese grandparents
who were born in Japan.
4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
5. Capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the ICD and in the
protocol.
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic,
psychiatric, neurological, dermatological, or allergic disease (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of
dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis
B core antibody (HBcAb), hepatitis B surface antibody (HBsAb) or hepatitis C antibody
(HCVAb).
4. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the
investigator's judgement.
5. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior 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 participant inappropriate for entry into
this study.
6. 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.
7. 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).
8. A positive urine drug test at screening or admission.
9. Screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at
least 5 minutes of supine rest.
10. Screening standard 12-lead single ECG that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline Fridericia-corrected QT [QTcF] interval >450 msec, complete left bundle
branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction,
ST-T interval changes suggestive of myocardial ischemia, second- or third-degree
atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
11. Participants with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study-specific laboratory and confirmed by a single
repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) level >=1.25 × upper limit of normal (ULN); total bilirubin
level >=1.5 × ULN, participants with a history of Gilbert's syndrome may have direct
bilirubin measured and would be eligible for this study provided the direct bilirubin
level is ULN; HbA1c >= 6.5%.
12. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.
13. Use of tobacco/nicotine containing products more than 5 cigarettes/day.
14. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.
15. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of the protocol.
16. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.