A DDI Study of FDL169 and FDL176 in Healthy Subjects
2020年1月30日 更新者:Flatley Discovery Lab LLC
A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
A DDI study to assess the safety, tolerability and pharmacokinetics of both; doses of FDL176 with and without co-administration of FDL169 and doses of FDL169 with and without co-administration of FDL176.
研究概览
详细说明
This is an open-label, non-randomised study.
Enrolment will be in two parallel and independent parts.
Part 1 will assess the safety, tolerability and pharmacokinetics of single doses of FDL176 with and without co-administration of FDL169.
Part 2 will assess the safety, tolerability and pharmacokinetics of repeated doses of FDL169 with and without co-administration of FDL176.
研究类型
介入性
注册 (预期的)
78
阶段
- 阶段2
- 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
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Belfast、英国、BT9 6AD
- Celerion GB Ltd
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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 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must agree to follow the study's contraception requirement
Exclusion Criteria:
- Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the subject or would place the subject at increased risk.
- History of long QT syndrome and/or QT corrected according to Fridericia's formula (QTcF) interval (>450 msec) or QTcF >450 msec at Screening or Day -1.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
- Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP.
- Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP.
- Use of any prescription and non-prescription medications that are strong inhibitors or moderate inducers of cytochrome P450 3A, within 14 days or 5-half-lives (whichever is longer) before the first dose of IMP. Use of any prescription and non-prescription medications that are strong inducers of cytochrome P450 3A within 28 days before the first dose of IMP.
- Participation in another clinical trial involving receipt of an IMP within the past 90 days.
- Prior exposure to FDL169 or FDL176
- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase >1.5 x upper limit of normal (ULN) at screening.
- Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
- Abnormal renal function at screening, defined as estimated glomerular filtration rate <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation.
- History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening.
- Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol breath test at Screening or Day -1. Consumption of alcohol within 24 h prior to admission.
- Consumption of any food or drink containing grapefruit, or Seville oranges (including marmalade and fruit juices) for 14 days before the first dose of IMP.
- Consumptions or foods containing poppy seeds or involvement in strenuous exercise for 3 days before admission.
- Known hypersensitivity to any component of the formulation of FDL169 or FDL176.
- Pregnant or nursing females.
- History of regular alcohol consumption within 6 months of the study
- Current smoking or use of tobacco products or substitutes.
- Poor peripheral venous access.
- Donation of ≥470 mL blood or loss of blood during surgery or due to trauma within 3 months prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Failure to satisfy the Investigator of their fitness to participate for any other reason.
- Site staff, Sponsor staff or first degree family members of site or Sponsor.
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:顺序分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Part 1
To receive a single dose of FDL176 on Day 1, followed by FDL169 TID for 28 days starting on Day 29; and another single dose of FDL176 on Day 42.
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CFTR校正器
CFTR potentiator
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实验性的:Part 2
To receive FDL169 TID for 3 days from Day 1, followed by FDL176 QD for 19 days starting on Day 8; and FDL169 TID for 3 days from Day 24.
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CFTR校正器
CFTR potentiator
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实验性的:Part 3
FDL169 and FDL176 for 28 days and 4 weeks of follow-up
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CFTR校正器
CFTR potentiator
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实验性的:Part 4
FDL169 and FDL176 for 28 days and 4 weeks of follow-up
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CFTR校正器
CFTR potentiator
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pharmacokinetic parameters, Cmax
大体时间:Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks
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Part 1: the pharmacokinetic parameters of FDL176 when co-administered with FDL169, compared to the pharmacokinetics of FDL176 alone.
Part 2: the pharmacokinetics of FDL169 when co-administered with FDL176, compared to the pharmacokinetics of FDL169 alone.
Part 3: PK when co-administered.
Part 4: Safety and tolerability with multiple dose co-administration in CF subjects
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Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
大体时间:Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks
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Safety and tolerability when FDL176 and FDL169 are co-administrated,compared to FDL176 alone, and FDL169 alone, as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
Part 4: Combination PK and CF transmembrane conductance regulator activity in CF subjects
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Part 1: 14 weeks; Part 2: 12 weeks; Part 3: 12weeks; Part 4: 12 weeks
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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。
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)
2018年11月27日
初级完成 (预期的)
2020年2月1日
研究完成 (预期的)
2020年2月1日
研究注册日期
首次提交
2018年11月27日
首先提交符合 QC 标准的
2018年11月27日
首次发布 (实际的)
2018年11月28日
研究记录更新
最后更新发布 (实际的)
2020年2月5日
上次提交的符合 QC 标准的更新
2020年1月30日
最后验证
2020年1月1日
更多信息
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.