EUCTR2011-000365-12-GB进行中（未招募）不适用
A randomized, open-label, five period, crossover study to evaluate the single dose pharmacokinetics and food effect of two pediatric AFQ056 formulations in healthy adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Healthy male and female subjects, aged 18 to 55 years and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.
- •3. Vital signs should be within normal ranges as deemed by the Investigator.
- •The Investigator should be guided by the following ranges (taken in a sitting position).
- •Oral body temperature between 35.0-37.5 °C
- •Systolic blood pressure, 90-140 mm Hg
- •Diastolic blood pressure, 50-90 mm Hg
- •Pulse rate, 50-90 bpm
- •When blood pressure and pulse are taken after at least 3 minutes standing, there should be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) (compared to the sitting results) associated with clinical manifestation of postural hypotension. Any subject exhibiting clinical manifestations of postural hypotension should be excluded.
- •4. Female subjects must be of non-child bearing potential. Women are considered postmenopausal females and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. (Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF). All female subjects must have negative pregnancy results at screening (regardless of reported reproductive status) and the first baseline visit.
- •5. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2.
- •6. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participation in any clinical investigation and/or use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •2. History of hypersensitivity to AFQ056 or to drugs of similar chemical classes
- •3. History or presence of clinically significant ECG abnormalities at screening.
- •The investigator may be guided by the following:
- •PR > 220 msec
- •QRS complex > 120 msec
- •History of Long QT syndrome
- •QTcF > 450 msec (males); QTcF > 470 msec (females)
- •4. History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or
- •psychiatric diseases.
- •5. History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •6. Pregnant or nursing (=lactating) women.
- •7. History or presence of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 6 months or history of suicidality as assessed by the investigator.
- •8. Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine = 500 ng/mL. Urine cotinine levels will be measured during screening for all subjects.
- •9. Use of any prescription drugs, herbal supplements (e.g. St. John’s wort) or over-thecounter (OTC) medication, within 30 days or 5 half-lives prior to initial dosing, whichever is longer , and/or dietary supplements (vitamins included) within two (2) weeks prior to initial dosing and during the entire study period until completion visit. If needed, (i.e. an incidental and limited need for analgesic treatment) paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the (e)CRF.
- •10. Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- •11. Recent (within the last three [3] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- •12. Any surgical or medical condition which might significantly alter the absorption,
- •distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
- •History or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal
- •History or presence of major gastrointestinal tract surgery such as gastrectomy,
- •gastroenterostomy, or bowel resection;
- •History or presence of pancreatic injury or pancreatitis;
- •History or presence of liver disease or injury as indicated by abnormal liver function
- •tests such as SGOT (AST), SGPT (ALT), ?-GT, alkaline phosphatase, or serum
- •bilirubin. The Investigator should be guided by the following criteria:
- •a. Any single parameter may not exceed 1.5 x upper limit of normal (ULN). A
- •single parameter elevated up to and including 1.5
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