Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study (DDI-COC)
2018年6月12日 更新者:Aquinox Pharmaceuticals (Canada) Inc.
Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects
This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).
研究概览
研究类型
介入性
注册 (实际的)
32
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
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Groningen、荷兰
- PRA Health Sciences - Early Development Serices
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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 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Aged 18-45 years, inclusive, at time of signing Informed Consent
- Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
- BMI 18.0 - 35.0 kg/m2
- Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator
Exclusion Criteria:
- Previous participation in the current study
- Any clinically significant history of breakthrough bleeding
- Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
- History of alcohol abuse or drug addiction
- Positive drug and alcohol screen at screening and (each) admission to the clinical research center
- Average intake of more than 24 units of alcohol per week
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study
- Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
- Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
- Unsuitable veins for blood sampling
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
- 介入模型:顺序分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Pre-Treatment, Treatment Cycles A & B
Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days. Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days. Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days |
Investigational Drug
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
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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 |
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Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination rate constant (Kel) of COC taken with AQX-1125
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination half-life (t1/2) of COC taken with AQX-1125
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Safety and tolerability of AQX-1125 200 mg qd administered with the COC
大体时间:16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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Safety and tolerability will be assessed by the severity and frequency of adverse events, which will include any abnormal clinically significant vital signs, laboratory tests, electrocardiogram and physical examination findings
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16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
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Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination rate constant (Kel) of AQX-1125 taken with COC
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
|
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
|
8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination half-life (t1/2) of AQX-1125 taken with COC
大体时间:8 Weeks (from start of treatment period A to completion of treatment period B)
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To assess the PK of 200 mg AQX-1125 qd when given together with the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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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)
2017年11月22日
初级完成 (实际的)
2018年3月29日
研究完成 (实际的)
2018年4月5日
研究注册日期
首次提交
2018年3月19日
首先提交符合 QC 标准的
2018年3月23日
首次发布 (实际的)
2018年3月27日
研究记录更新
最后更新发布 (实际的)
2018年6月13日
上次提交的符合 QC 标准的更新
2018年6月12日
最后验证
2018年6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.
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