Single-ascending dose of CEP 37251 in Healthy Postmenopausal Women

Exclusion Criteria8

• The subject has received any of the following medications within the 6 months prior to enrollment: 1a) hormone replacement therapy 1b) selective estrogen receptor modulator (SERM) therapy such as raloxifene 1c) elemental calcium supplementation >1.5 g/day 1d) Vitamin D supplementation >1000 IU per day 1e) calcitriol or other Vitamin D analogs of calcitrol (eg, alfacalcidol, doxercalciferol, or paricalcitol) 1f) calcitonin or parathyroid hormone 1g) glucocorticoids and/or anabolic steroids
• The subject has received bisphosphonates or fluoride within the 12 months prior to enrollment.
• The subject has any of the following concomitant conditions: 3a) hypo- or hyperthyroidism. NOTE: Subjects with treated hypothyroidism with normal thyroid parameters may be allowed to participate in the study at the discretion of the investigator and medical monitor. 3b) hypo- or hyperparathyroidism 3c) recent fracture (within 6 months) 3d) osteomalacia, Paget’s Disease, osteopetrosis, osteogenesis imperfecta, or other bone disease 3e) rheumatoid arthritis or psoriatic arthritis 3f) acute osteoarthritis or gout 3g) chronic kidney disease or renal failure defined as an estimated glomerular filtration rate (eGFR) (by Modification of Diet in Renal Disease (MDRD) equation) 30 mL/min/1.73m2 or less
• The subject is receiving immunosuppressant drugs.
• The subject has evidence of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease, or malabsorption syndrome.
• The subject has a known history or evidence of malignancy, lymphoproliferative, or neoplastic disease with the exception of being successfully treated for basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
• The subject has a known or suspected hypersensitivity or idiosyncratic reaction to any compound present in the study drug or placebo.
• The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000). NOTE: A unit of alcohol is equal to approximately 30 ml of spirits, 100 ml of wine, or 260 ml of full-strength beer.