NCT01969656已完成1 期
A Phase 1B, Double-Blind, Placebo-Controlled, Calcitriol Active-Controlled, Daily-Dose, Escalating-Dose, Safety and Tolerance Study of 2MD Soft Gel Capsules in Normal Healthy Postmenopausal Women
Deltanoid Pharmaceuticals0 个研究点开始时间: 2013年10月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 主要终点
- Change from baseline in total serum calcium
研究概览
简要总结
Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Normal healthy postmenopausal women, ≥ 60 but ≤ 80 years of age, or between 45 and 60 years of age who have been amenorrheic for at least 2 years plus have a serum FSH level of > 30 IU/L, or women with a documented bilateral oophorectomy at least 2 years prior to study start.
- •Within ±30% of their ideal body weight for height and body frame.
- •Demonstrated ability to understand and willingness to sign an Informed Consent Form.
- •24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.
- •Negative urine test for selected drugs of abuse.
- •Willing to maintain a total calcium intake between 700 and 1000 mg/day.
排除标准
- •Any acute or chronic condition that would limit the subject's ability to complete the study.
- •Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
- •History or presence of any diseases known or believed to influence calcium absorption or metabolism.
- •History of renal calculi.
- •History of an eating disorder.
- •History of stomach or intestinal surgery.
- •History of hypersensitivity or allergies to any vitamin D derivative.
- •History or presence of an abnormal ECG.
- •Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
- •Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
- •Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
- •Use of vitamin and/or mineral supplements >1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
- •Poor peripheral venous access.
- •Receipt of blood products within 2 months prior to study entry.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Calcitriol
Active Comparator
干预措施: Calcitriol (Drug)
50 ng 2MD
Experimental
干预措施: 2MD (Drug)
110 ng 2MD
Experimental
干预措施: 2MD (Drug)
170 ng 2MD
Experimental
干预措施: 2MD (Drug)
220 ng 2MD
Experimental
干预措施: 2MD (Drug)
440 ng 2MD
Experimental
干预措施: 2MD (Drug)
结局指标
主要结局
Change from baseline in total serum calcium
时间窗: Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose
Change from baseline in levels of 2MD in the blood
时间窗: 1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27
次要结局
未报告次要终点
研究者
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