Single-ascending dose of CEP 37251 in Healthy Postmenopausal Wome

Phase 1

• Conditions: Osteoporosis in Healthy Postmenopausal Women; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12610000379011
• Lead Sponsor: Cephalon, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

1. The subject is a postmenopausal woman aged 40 years or greater but less than 75 years.
2.The subject is considered to be postmenopausal if at least 1 of the following criteria is met: 1a) aged 50 or more years and has had a lack of menses for 12 or more months 1b) aged 40 or more and less than 50 years, has had a lack of menses for 12 or more months, and serum estradiol is 20 ng/mL or less or follicular stimulating hormone (FSH) is 50 IU/L or greater 1c) aged 40 or more years and has had bilateral surgical oophorectomy 1d) aged 40 or more years, has had a hysterectomy, and serum estradiol is 20 ng/mL or less or FSH is 50 IU/L or greater
3. The subject has a body weight greater than 50 kg but no more than 100 kg with a body mass index (BMI) of 18 to 35 kg/m2

Exclusion Criteria

1 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
2 The subject has received bisphosphonates or fluoride within the 12 months prior to enrollment.
3 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
4 The subject is receiving immunosuppressant drugs.
5 The subject has evidence of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease, or malabsorption syndrome.
6 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.
7 The subject has a known or suspected hypersensitivity or idiosyncratic reaction to any compound present in the study drug or placebo.
8 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified