Safety, Tolerability, and Pharmacokinetics of Oral SCY-247 in Healthy Subjects: Part 4

Exclusion Criteria24

• Underlying psychological medical condition that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
• Subject has a history of any illness or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.
• Subject has a history of fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening.
• Subject has poor pill swallowing ability.
• Subject has an estimated creatinine clearance less than equal to 80 mL/min based on the CockcroftGault equation, as follows:
• o Estimated creatinine clearance equals to [(140 – age) x weight in kg] / [72 x serum creatinine in mg/dL] [x 0.85 if female].
• Subjects who have an estimated creatinine clearance up to 10% below 80 mL/min may be enrolled in the study at the discretion of the investigator.
• Subject has risks for QT prolongation including a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds for males and >470 milliseconds for females).
• Subject has a history of additional significant risk factors for torsade de pointes (e.g., family history of Long QT Syndrome).
• Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John’s Wort [hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit. There may be certain medications eg paracetamol, vitamins, ibuprofen that are permitted at investigator’s discretion.
• Subject has a history of stroke, chronic seizures or major neurological disorder.
• Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory or genitourinary abnormalities or diseases. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator.
• Subject has a history of neoplastic disease or any active cancer, except for non-melanoma skin cancer, excised more than 2 years before screening, and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
• Subject has a history of liver disease, including chronic hepatitis, or aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or Total Bili >1.5 × upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out-of-range values based on investigator’s discretion.
• Subject has a history of human immunodeficiency virus (HIV), hepatitis C (HCV) antibodies, and hepatitis B surface antigen (HBsAg).
• Regular alcohol consumption defined as > 10 standard drinks per week (where 1 standard drink equals to 360 mL of beer, 45 mL of 40% spirit or a 150 mL glass of wine) or > 4 standard drinks on any single day. Subject is unwilling to refrain from all alcohol consumption beginning 72 hours prior to first administration of study drug and throughout the study until the final study visit.
• Subject consumes excessive amounts of caffeine for one month prior to study drug administration, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other caffeinated beverages per day.
• Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 30 days or 5 half-lives of the investigational product prior to the screening. The 30-day window will be derived from the date of the last study procedure (i.e., poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study.
• Subject was vaccinated with a live vaccine within 4 weeks prior to the first administration of the study drug.
• Subject has a history of significant multiple and/or severe allergies [including latex allergy, but with exception of seasonal rhinitis (hay fever)] or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
• Subject is currently an abuser including illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
• Subject tested positive for drugs of abuse, including amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, methadone and opiates at screening or Day -1.
• There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason the investigator considers the subject inappropriate for participation in the study.
• Subject is unable to abstain from strenuous exercise from 48 hours prior to Day - 1 throughout the study until the poststudy visit.