| Eligibility |
Inclusion Criteria:
- The subject must be a lactating female who had a normal full-term pregnancy and has
been actively breastfeeding or pumping for at least 4 weeks; lactation must be well
established per Investigator discretion.
- The subject must be willing to pump regularly during the study to maintain milk supply
and discontinue breastfeeding for the entire 13-day Treatment and Washout Periods.
- The subject must not be pregnant.
- The subject must be surgically sterile or willing to use 1 acceptable method of birth
control.
Exclusion Criteria:
- Has clinically significant infection (e.g., pneumonia, pyelonephritis) or chronic
infection within 30 days prior to enrollment.
- Has evidence of unstable or uncontrolled, clinically significant cardiovascular,
central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary,
hematological, coagulation, immunological, endocrine/metabolic, or other medical
disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures, or
allergic skin rash, that, in the opinion of the Investigator, would confound the study
results or compromise subject safety.
- Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.732 using the
Modification of Diet in Renal Disease (MDRD) formula.
- Has liver disease or dysfunction characterized by Child-Pugh Class B or Class C.
- History of any major neurological disorders, including stroke, multiple sclerosis,
brain tumor, or neurodegenerative disease.
- Has active psychiatric problems that, in the Investigator's opinion, may interfere
with compliance with the study procedures.
- Has history of breast implants, breast augmentation, or breast reduction surgery.
- Has a prior history of difficulty establishing lactation.
- Gastrointestinal conditions or procedures (including weight loss surgery; e.g.,
Lap-Band® or gastric bypass) that may affect drug absorption.
- Any history of malignancy (with the exception only of basal or squamous cell carcinoma
of the skin in individuals that have been cancer free for >5 years).
- History within the last 2 years of drug, alcohol, amphetamine and derivatives, or
cocaine abuse.
- Current smoker.
- Blood donation, participation in a multiple blood draw clinical study, major trauma,
or surgery with or without blood loss within 30 days prior to enrollment.
- Blood transfusion for any reason within 90 days prior to enrollment.
- Use of any 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor
(statin) concurrently or within 30 days prior to randomization.
- Use of cyclosporine, cholestyramine, probenecid, fibrate drugs, or medications
contraindicated during lactation concurrently or within 30 days prior to
randomization.
- Concomitant use or use within 30 days prior to randomization of drugs that decrease
breast milk production, such as pseudoephedrine.
- Concomitant use or use within 30 days prior to randomization of drugs that increase
breast milk production, such as domperidone.
- Use of any experimental or investigational drugs/vaccines concurrently or within 30
days or 5 half-lives of the drug, whichever is longer, prior to screening.
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