NCT00888069已完成1 期
A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
研究概览
简要总结
This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2
- •Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL
- •Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL
- •Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
- •Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
- •Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL
- •Hemoglobin level greater than or equal to 10 g/dL
排除标准
- •Has nephrotic range proteinuria
- •Has liver disease or significant hepatic dysfunction
- •Is taking Cytochrome P450 3A4 inhibitors or inducers
- •Has adult history of kidney stones and dysphagia
- •Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen
- •Currently on dialysis
- •Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
研究组 & 干预措施
Low Dose CTAP101 Capsules
Experimental
CTAP101 Capsules, 450 mcg dose
干预措施: CTAP101 Capsules (Drug)
High Dose CTAP101 Capsules
Experimental
CTAP101 Capsules, 900 mcg dose
干预措施: CTAP101 Capsules (Drug)
CTAP101 Injection
Experimental
IV injection, 448 mcg dose
干预措施: CTAP101 Injection (Drug)
结局指标
主要结局
To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT
时间窗: from 3 to 0 hours prior to dosing until 42 days post dosing
次要结局
- To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT.(From signing of ICF (Day -35) through study completion (Day 42 post dosing))
- To assess the safety and tolerability of CTAP101 capsules and injection(From signing of ICF (Day -35) through study completion (Day 42 post dosing))
研究者
研究点 (12)
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