Relative Bioavailability Study of Ganciclovir From the Pro-drug, Valganciclovir, in Lung Transplant Recipients With or Without Cystic Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)
研究概览
简要总结
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokinetic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients, >=14 years of age;
- •first lung or heart-lung transplant recipient;
- •at risk of CMV disease (D+R-,D+R+ or D-R+);
- •estimated creatinine clearance >=60mL/min;
- •stable immunosuppressive and 900mg Valcyte dosing regimens (>=4 days) prior to pharmacokinetic assessments.
排除标准
- •history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir;
- •evidence of graft rejection;
- •patient has received anti-CMV prophylaxis with a treatment other than cytogam, ganciclovir or valganciclovir between transplant and screening.
研究组 & 干预措施
1
干预措施: valganciclovir [Valcyte] (Drug)
结局指标
主要结局
Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)
时间窗: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose
The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Ganciclovir
时间窗: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose
The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.
次要结局
- Plasma Half-Life (T1/2) of Ganciclovir(Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose)
- Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir(Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose)
- Apparent Elimination Rate (Kelim) of Ganciclovir(Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose)