CTRI/2021/03/032206尚未招募1 期
A PHASE 1 OPEN LABEL, RANDOMIZED, TWO-PERIOD, SINGLE AND MULTIPLE-DOSE,SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC, STUDY OFAT-10 IN HEALTHY HUMAN SUBJECTS CONSIDERED AS EXTENSIVE AND POORMETABOLIZERS OF CYP2C19 BASED ON GENOTYPING
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- safety and tolerability of AT-10 compared to Clopidogrel administered orally to humans.
研究概览
简要总结
This is a Phase 1 Open Label, Randomized, Two-Period, Single and Multiple-Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic, Study of AT-10 in Healthy Human Subjects considered as Extensive and Poor Metabolizers of CYP2C19 based on Genotyping. 40 healthy adult Indian human subjects who are randomized in 1:1 ratio as poor and extensive metabolizers will be given AT-10 or Clopidogrel loading and maintenance doses over 6 days. The primary outcome will be to check the safety and tolerability of AT -10 compared to Clopidogrel and their effect on platelet aggregation in poor and extensive metabolizers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are willing to provide voluntary informed consent and are willing to participate in the study.
- •Normal healthy human adult male and/or female subjects between 18-45 years (both ages inclusive) of age.
- •Body Mass Index of 18.50 to 29.90 kg/m2 (both inclusive).
- •No evidence of underlying disease during the pre-study screening, medical history, clinical examination and laboratory investigations performed within 28 days prior to commencement of the study.
- •Subject classified as extensive (normal) metabolizer or poor metabolizer based on CYP2C19 allele 1, 2, 3 and 17 genotyping.
- •Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
- •Negative test results for alcohol, drugs of abuse, Beta hCG test (for female subjects only) and who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR at the time of screening.
- •12-lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study.
排除标准
- •Known allergic to Clopidogrel, AT-10 or any component of the formulation and to any other related class of drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •Female subjects who are nursing motherslactating women.
- •History/presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year.
- •History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
- •History/presence of significant Asthma, urticaria or other allergic type reactions after taking any medication.
- •History/presence of clinically significant illness within 04 weeks before the start of the study.
- •History/presence of significant Hypersensitivity to heparin.
- •History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
- •Platelet count outside the normal range at screening or housing for Period 1 10) Subjects scheduled for surgery any time during study or within 07 days after study completion.
- •Subjects who have taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP, including topical medication.
- •Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication (e.g. Omeprazole or other proton pump inhibitors).
结局指标
主要结局
safety and tolerability of AT-10 compared to Clopidogrel administered orally to humans.
时间窗: 6 days
effect of AT -10 (loading and maintenance doses) Vs the approved doses of Clopidogrel (loading and maintenance doses) on
时间窗: 6 days
platelet aggregation in poor and extensive metabolizers.
时间窗: 6 days
次要结局
- single and multiple dose pharmacokinetics (PK) of(Clopidogrel, AT -10, and active metabolite MP-H4)
研究者
研究点 (1)
Loading locations...
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