ACTRN12619000961145已完成1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen in Healthy Female Volunteers
Atossa Genetics AUS Pty Ltd0 个研究点目标入组 25 人开始时间: 2019年7月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •1. Healthy adult females, 18 to 65 years of age (inclusive) at the time of screening;
- •2. Body Mass Index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening;
- •3. Absence of significant diseases which, at the physician's discretion, could have an impact on the volunteer's participation in the trial, according to protocol requirements, and study evaluations;
- •4. Medically healthy without clinically significant abnormalities at the screening visit or Day -1,including:
- •a. Electrocardiogram (ECG),
- •b. Physical examination, vital signs including temperature, heart rate, respiratory rate and
- •blood pressure;
- •5. Screening laboratory tests that are deemed to be non-clinically significant by the investigator;
- •6. Negative cotinine, drug and alcohol tests at screening and check in;
- •7. Ability to understand the nature and objectives of the trial, including risks and adverse events;
- •willingness to cooperate with the researcher and proceed according to all study requirements;
- •8. Participants of child-bearing potential (a woman is considered of child-bearing potential unless she is permanently sterilized or post-menopausal for at least 12 months with no menses and no alternative medical cause) must agree to use one of the following appropriate contraceptive methods (hormonal contraception is not permitted)
- •Complete abstinence from intercourse (with a male partner) for at least 14 days prior to dosing with study drug through the End-of-Study and at least 60 days after the conclusion of study drug administration, provided it is true abstinence consistent with the usual and ongoing lifestyle of the participant.
- •b. A double-barrier method, i.e., condom and IUD;
- •c. Sterilization (vasectomy) of male partner prior to commencement of the volunteer’s last normal menstrual
- •9. Have no air travel commitments during the study and for four weeks following completion of the
- •study treatment;
- •10. Have suitable venous access for blood sampling;
- •11. Willing and able to comply with the requirements of the study protocol.
排除标准
- •1. Current or recent use of (within 3 months) of cigarettes or any other tobacco-containing product.
- •2. Unexplained vaginal bleeding
- •3. History or presence of:
- •a. a clinically significant disorder including but not limited to: cardiovascular, pulmonary (with the exception of mild asthma – no prevention treatment within prior 6 months), hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past three months determined by the PI to be clinically relevant;
- •b. deep vein thrombosis, pulmonary embolism or significant thrombosis in any other vein
- •c. endometrial cancer, premalignant condition of the endometrium or a strong family history of endometrial cancer;
- •d. arterial thrombotic disease such as stroke, coronary artery disease or peripheral vascular disease
- •e. cataracts or retinal vein occlusion
- •f. drug addiction, including alcohol, within 1 year;
- •4. A family history (first degree relative) of venous thrombosis that was NOT due to a transient major risk factor, i.e., hip surgery, knee replacement.
- •5. Current or recent (within 3 months) use of alcohol that exceeds 3 standard drinks per day
- •6. Have a hypersensitivity or allergy to the investigational compound/compound class being used in this study or any ingredients of this medication;
- •7. Treatment, within 3 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
- •8. Have participated in any other investigational study within 30 days of screening;
- •9. Use of any medications or over the-counter products within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication (including analgesics (paracetamol up to and including 2 g per day is permitted), herbal products or diet aids);
- •10. Have received hormonal treatment (including use of hormonal contraceptives (oral contraceptive pills or implant)) within 3 months prior to commencement of study treatment;
- •11. Pregnancy, labour or miscarriage within 12 weeks before commencement of study treatment;
- •12. Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrolment.
- •13. Any conditions, that according to investigator's best judgment, prevent participation in the trial.
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