ABOUT THIS STUDY
- Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Female research subjects of non-childbearing potential
- Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight >50 kg (>110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the research subject has been informed of all pertinent aspects of the study.
- Research subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
- Clinically significant infections within the past 3 months, evidence of any infection
within the past 7 days, history of disseminated herpes simplex infection or recurrent
(>1 episode) or disseminated herpes zoster.
- Evidence or history of cyclic neutropenia.
- Personal or family history of hereditary immunodeficiency (eg, severe combined
immunodeficiency disorder [SCID], Wiskott Aldrich syndrome, X linked
- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing, or is to
be vaccinated with these vaccines at any time during treatment or within 6 weeks
following discontinuation of dosing.
- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,
- Research subjects with a history of, or current evidence for, severe gastrointestinal
narrowing (pathologic or iatrogenic).
- History of or current positive results for any of the following serological tests:
hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti hepatitis
C core antibody (HCV Ab), or human immunodeficiency virus (HIV) 1 and 2.
- A positive urine drug test.
- A positive alcohol screen.
- History of regular alcohol consumption exceeding 14 drinks/week for female research
subjects or 21 drinks/week for male research 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.
- Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 3
cigarettes, so research subjects would be limited to 2 or less chews per day.
- Treatment with an investigational drug within 6 months or 5 half lives preceding the
first dose of investigational product (whichever is longer).
- Pregnant female research subjects, breastfeeding female research subjects, fertile
male research subjects and female research subjects of childbearing potential who are
unwilling or unable to use a highly effective method of contraception as outlined in
this protocol from at least 14 days prior to the first dose of investigational product
until at least 28 days after the last dose of investigational product.
- A positive beta human chorionic gonadotropin test for women of childbearing potential.
- Use of prescription or nonprescription drugs and dietary supplements within 14 days or
5 half lives (whichever is longer) prior to the first dose of investigational product.
- Herbal supplements, hormonal methods of contraception (including oral and transdermal
contraceptives, injectable progesterone, progestin subdermal implants, progesterone
releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive
methods), and hormone replacement therapy must have been discontinued at least 28 days
prior to the first dose of investigational product.
- Depo Provera must have been discontinued at least 6 months prior to the first dose of
- Consumption of grapefruit or grapefruit related citrus fruits (eg, Seville oranges,
pomelos) or juices within 7 days prior to dosing.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 3 months prior to screening.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- History of hypersensitivity to sertraline or any of the components in the formulation
of the study products.
- 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 research subject inappropriate for entry
into this study.
- Research subjects who are 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 research subjects who are the sponsor's employees, including
their family members, directly involved in the conduct of the study.
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