A Study to Investigate the Safety of SEP-786 101 Capsules Compared With Placebo Capsules in Healthy Volunteer Participants Aged 24 Through 55 Years

Exclusion Criteria34

• Have a history or presence of any of the following:
• a. Malignant disease, other than basal cell epithelioma/carcinoma or completely resected squamous skin cancer with no recurrence for 12 months
• b. Diabetes mellitus
• Note: a history of gestational diabetes that is fully resolved is permitted.
• c. Hyperparathyroidism, hypoparathyroidism, hypercalcemia, hypercalciuria, kidney stones, familial benign hypocalciuric hypercalcemia, osteomalacia, Paget’s disease, osteoporosis, or any type of metabolic bone disease or radiation therapy to the skeleton
• d. Cardiac dysfunction, including abnormal echocardiogram left ventricular ejection fraction (LVEF) <50%, congestive heart failure, long QT syndrome, valvular heart disease except clinically insignificant mitral valve prolapse, hypertrophic cardiomyopathy, or cardiovascular disease
• e. Cerebrovascular disease
• f. Thromboembolic events or ischemic heart disease
• g. Alcoholism or drug abuse within the past 1 year
• Note: Alcohol abuse is considered >14 standard drinks/week in AFAB potential participants and >21 standard drinks/week in AMAB potential participants.
• h. Stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• i. Clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator or designee
• j. Hepatitis B (defined as HBsAg reactive) or hepatitis C (defined as HCV antibody–positive) at screening
• k. Human immunodeficiency virus (HIV) positive status (participants to be screened for HIV or provide a recent negative test)
• Have an acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days of the first dose of study intervention
• Have a positive COVID 19 polymerase chain reaction (PCR) test at admission
• Are unable to refrain from using or anticipate the use of any drug or medical device, including prescription and over the counter (OTC) medications, nutritional or dietary supplements, recreational drugs, herbal preparations, or vitamins, from Day -7 until follow up visit, or as specified below:
• a. From Day -28 for significant inhibitors or inducers of CYP enzymes and/or P gp, including St. John’s wort, to discharge from CRU
• b. From Day -42 for PPIs, supplements containing calcium (Ca) or magnesium (Mg) (including Tums®), and H2 antagonists until discharge from CRU
• Exceptions:
• a. Acetaminophen, which may be used at doses of 1 gram or less per day until 24 hours prior to check in
• b. OTC nonsteroidal anti inflammatory drug (NSAIDs), which may be used until 24 hours prior to check in
• c. OCPs or an intrauterine device (IUD) or intrauterine hormone releasing system (IUS)
• d. Any drug approved by the medical monitor
• Have participated in another clinical study within 28 days prior to the first dose of study drug or at least 5.5 half lives, based on the t1/2 for the investigational drug, whichever is longer. The 28 day window is derived from date of the previous study’s last scheduled blood collection or dosing, whichever was later, to Day 1 of the current study.
• Have clinically significant abnormalities on clinical laboratory results (including hematology, chemistry, and urinalysis) at screening and Day -2
• Have evidence of endocrine alterations of calcium/phosphate/PTH homeostasis at screening
• Have donated blood within 7 days of the first dose of study intervention or have had significant (ie, >=500 mL) blood loss within 8 weeks of the first dose of study intervention
• Have used tobacco within 60 days of screening at a rate of >5 units (cigarettes or vaping equivalents)/week
• Have consumed alcohol within 24 hours of check in
• Have a known hypersensitivity to the components of the study intervention
• Are likely to be noncompliant with respect to study conduct
• Are mentally or legally incapacitated or have significant emotional problems at the time of the screening visit or expect to have any during the conduct of the study
• Have any other reason that, in the opinion of the investigator or designee, would prevent the participant from completing participation or following the study schedule