A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
2017年11月29日 更新者：Achaogen, Inc.
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and the Drug-Drug Interaction Potential of Oral ACHN-383 and ACHN-789 in Healthy Subjects
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Perth、澳大利亚
- Clinical Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
- Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
- Body mass index (BMI) of ≥19 kg/m^2 to ≤32 kg/m^2 and weight ≥50 kg to ≤125 kg
- Normal renal function as determined by creatinine clearance (CLcr) rate
Key Exclusion Criteria:
- Pregnant women
- History of any hepatic or biliary disorder or disease
- Any condition that could possibly affect oral drug absorption
- Unstable cardiovascular disease
- Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
- HIV positive
- Active malignancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1
Healthy volunteers
|
口服剂量
Oral dose
Oral dose
|
|
实验性的：Cohort 2
Healthy volunteers
|
口服剂量
Oral dose
Oral dose
|
|
实验性的：Cohort 3
Healthy volunteers
|
口服剂量
Oral dose
Oral dose
|
|
实验性的：Cohort 4
Healthy volunteers
|
口服剂量
Oral dose
Oral dose
|
|
实验性的：Cohort 5
Healthy volunteers
|
口服剂量
Oral dose
Oral dose
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Changes from baseline in clinical laboratory values (CBC, serum chemistry, urine analysis, AST, ALT, ALP, serum bilirubin)
大体时间：26 days
|
26 days
|
|
Changes from baseline in vital signs (temperature, pulse, respiration, blood pressure)
大体时间：26 days
|
26 days
|
|
Incidence and severity of adverse events
大体时间：26 days
|
26 days
|
|
Changes from baseline in the QTcF interval
大体时间：19 days
|
19 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Maximum peak observed concentration (Cmax) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Time to maximum concentration (Tmax) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Area under the concentration-time curve (AUC) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Half-life (t1/2) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Apparent systemic clearance (CL/F) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Apparent volume of distribution (Vz/F) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Amount excreted in urine (Ae) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-789
大体时间：1 day
|
1 day
|
|
PK parameter: Renal clearance (CLr) after single-dose administration of ACHN-383
大体时间：3 days
|
3 days
|
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：1 day
|
1 day
|
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：5 days
|
5 days
|
|
PK parameter: Cmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: Tmax after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: AUC after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: t1/2 after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: CL/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: Vz/F after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: Ae after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: CLr after single-dose administration of ACHN-383 and ACHN-789 given concurrently 30 minutes after a high-fat, high-calorie meal
大体时间：6 days
|
6 days
|
|
PK parameter: Cmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: Cmin after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: Tmax after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: AUC after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: t1/2 after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: CL/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: Vz/F after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: Ae after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
PK parameter: CLr after multiple-dose administration of ACHN-383 and ACHN-789 given concurrently
大体时间：19 days
|
19 days
|
|
Urine concentrations of ACHN-789 after single dose administration
大体时间：1 day
|
1 day
|
|
Urine concentrations of ACHN-383 after single-dose administration
大体时间：3 days
|
3 days
|
|
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
大体时间：1 day
|
1 day
|
|
Urine concentrations of ACHN-383 and ACHN-789 after single-dose administration given concurrently
大体时间：5 days
|
5 days
|
|
Urine concentrations of ACHN-383 and ACHN-789 after multiple-dose administration given concurrently
大体时间：19 days
|
19 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Daniel J Cloutier, PharmD、Achaogen, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月17日
初级完成 (实际的)
2017年10月15日
研究完成 (实际的)
2017年10月15日
研究注册日期
首次提交
2017年5月15日
首先提交符合 QC 标准的
2017年5月20日
首次发布 (实际的)
2017年5月23日
研究记录更新
最后更新发布 (实际的)
2017年12月2日
上次提交的符合 QC 标准的更新
2017年11月29日
最后验证
2017年11月1日
更多信息
与本研究相关的术语
其他研究编号
- ACHN-172-001
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
-
City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的