- Healthy males and female of non-childbearing potential;
- Age of 18-55, inclusive;
- Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
- Body weight greater than 50 kg;
- Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior
to first dose.
- Evidence of history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergises, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing);
- Subjects with fasting LDL-C level >190 mg/dL following an overnight fast of at least
10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
- Subjects with fasting TG level >400 mg/dL following an overnight fast of at least 10
hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug test.
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
14 drinks/week for male subjects (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.
- Treatment 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
(whichever is longer).
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day or 2 chews of tobacco per day.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; fertile male subjects 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.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.
- 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 subject inappropriate for entry into this
study.