A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy postmenopausal females, as determined by medical history and physical examination
- •Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive
- •Acceptable Clinical laboratory test results, blood pressure and heart rate
- •Have given written informed consent
- •Additional Inclusion Criterion for Participants in Open Label Groups: Are currently taking or recently discontinued (not more than 3 months prior to study randomization) alendronate and have taken alendronate for at least 12 of the last 18 months
排除标准
- •Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- •Known allergies to LY2541546, its constituents, or related compounds
- •Persons who have previously participated in this study
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- •History of or high risk for adverse outcome from bleeding, for example, transient ischemic attacks, cerebrovascular attacks, and ulcer disease
- •Paget's disease, parathyroid disease, or thyroid disease
- •Fracture of a long bone within 12 weeks of screening
- •Regular use of known drugs of abuse and/or positive findings on urinary drug screening
- •Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen
- •Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months
- •Blood donation within the last month
- •Participants who have an average weekly alcohol intake that exceeds 14 units per week
- •Cigarette consumption of more than 10 cigarettes per day, or are unable or unwilling to refrain from nicotine during Clinical Research Unit (CRU) confinement
- •Additional Exclusion Criterion for Participants in Double Blind Groups Only
- •Have received bisphosphonates during the previous 24 months.
- •Additional Exclusion Criterion for Participants in Open Label Groups
- •Have received intravenous bisphosphonates within the previous 18 months
研究组 & 干预措施
7.5 mg LY2541546 - IV
Single dose of 7.5 mg LY2541546 administered intravenously (IV)
干预措施: LY2541546 - IV (Drug)
25 mg LY2541546 - IV
Single dose of 25 mg LY2541546 administered IV
干预措施: LY2541546 - IV (Drug)
75 mg LY2541546 - IV
Single dose of 75 mg LY2541546 administered IV
干预措施: LY2541546 - IV (Drug)
225 mg LY2541546 - IV
Single dose of 225 mg LY2541546 administered IV
干预措施: LY2541546 - IV (Drug)
750 mg LY2541546 - IV
Single dose of 750 mg LY2541546 administered IV
干预措施: LY2541546 - IV (Drug)
150 mg LY2541546 - SC
Single dose of 150 mg LY2541546 administered subcutaneous (SC)
干预措施: LY2541546 - SC (Drug)
Placebo
Single dose of placebo administered IV or SC
干预措施: Placebo (Drug)
225 mg LY2541546 - IV, OL
Single dose of 225 mg LY2541546 administered IV, open label (OL)
干预措施: LY2541546 - IV (Drug)
750 mg LY2541546 - IV, OL
Single dose of 750 mg LY2541546 administered IV, OL
干预措施: LY2541546 - IV (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Day 1 through Day 85
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * or is considered significant by the investigator for any other reason.
次要结局
- Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)(Baseline (predose), Day 29 anytime, Day 85 anytime)
- Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)(Baseline (predose), Day 29 anytime, Day 85 anytime)
- Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies(Day 1: Predose, Day 29 anytime, Day 85 anytime)
- Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546(Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime)