ACTRN12619001623189已完成1 期
A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen Tablets in Healthy Female Volunteers
Atossa Genetics Aus Pty Ltd0 个研究点目标入组 12 人开始时间: 2019年11月22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
- 12
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 18.0 to 32.0 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)
- •a. 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. Vasectomy with confirmed azoospermia on laboratory testing 3 months prior to screening of volunteer and the male partner is the sole partner for that female volunteer;
- •9. Female participants of non-childbearing potential must meet one of the following criteria:
- •a. Sterilised, by bilateral tubal ligation or oophorectomy;
- •b. Hysterectomy,
- •c. Post-menopausal for at least 12 months with FSH >40 IU/L.
- •10. Have no air travel commitments during the study and for four weeks following completion of the study treatment;
- •11. Have suitable venous access for blood sampling;
- •12. 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. History of deep vein thrombosis, pulmonary embolism or significant thrombosis in any
- •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
- •e. Cataracts or retinal vein occlusion;
- •f. Drug addiction, including alcohol, within 1 year;
- •4. Family history (first degree relative) of venous thrombosis that was NOT due to a transient major risk factor, i.e., hip surgery, knee replacement, etc;
- •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 the 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, according to the investigator's best judgment, prevent participation in the trial.
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