NCT01134549已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers
KAI Pharmaceuticals0 个研究点目标入组 32 人开始时间: 2010年6月9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
- 入组人数
- 32
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 18 and 45 years of age who have provided written informed consent
- •Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests
排除标准
- •History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator
- •History of any ongoing medical condition requiring treatment with prescription medication
- •History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions
- •Clinically significant abnormalities on screening clinical examination or laboratory safety tests
- •History of drug or alcohol abuse
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received a single dose of placebo intravenous injection.
干预措施: Placebo (Drug)
Etelcalcetide
Experimental
Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose of study drug through 7 days.
次要结局
- Percent Change From Baseline in Serum Parathyroid Hormone(Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose)
- Change From Baseline in Serum Corrected Calcium(Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose)
- Percent Change From Baseline in Serum Calcitonin(Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose)
- Percent Change From Baseline in Plasma Ionized Calcium(Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose)
- Change From Baseline in Serum Total Calcium(Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose)
- Change From Baseline in Serum Phosphate(Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose)
- Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D(Baseline and 12, 24, and 48 hours post-dose)
- Maximum Observed Concentration (Cmax) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Terminal Elimination Rate Constant (λz) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Total Body Clearance (CL) for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
- Number of Participants With Antibodies to Etelcalcetide(Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.)
- Volume of Distribution at Steady State for Etelcalcetide(Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.)
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