None listed
Conditions
Brief summary
The purpose of this study is to test the safety and tolerability of a potential breast cancer treatment called endoxifen. Who is it for? You may be eligible for this study if you are a healthy female aged 18-65. [***Please note participants who have cancer are not eligible for this study.***] Study details Participants in this study will receive tablets, to be taken by mouth and will be randomised (by chance) to either the active drug or a placebo. Neither the participant nor investigators will know who gets the active or placebo drug. Initially, only a single tablet will be taken. After checking the results of this first day, participants continue into the second part of the study where they will take their assigned tablet once a day for another 14 days. As part of this study, all participants will need to provide blood samples, urine samples, answer questionnaires and have a physical exam.
Interventions
This is a single and multiple dose study with participants receiving oral (Z)-endoxifen 4mg tablets or placebo tablets. Participants will be assigned to the same allocated study treatment ((Z)-endoxifen or placebo) through both Part A and Part B.
12 healthy female volunteers will be screened 28 days prior to commencement of dosing.
Participants will be admitted to the clinical facility on Day -1 for up to 3 days in Part A (single dose). Participants will also be admitted for a second confinement
This is a single and multiple dose study with participants receiving oral (Z)-endoxifen 4mg tablets or placebo tablets. Participants will be assigned to the same allocated study treatment ((Z)-endoxifen or placebo) through both Part A and Part B. 12 healthy female volunteers will be screened 28 days prior to commencement of dosing. Participants will be admitted to the clinical facility on Day -1 for up to 3 days in Part A (single dose). Participants will also be admitted for a second confinement period in Part B (multiple dose) on Day 13 for up to 3 days. Part A: Single Dose The first dose of study drug (one 4mg (Z)-endoxifen tablet or placebo tablet) will be administered on Day 1. Following completion of all safety assessments and sampling for PK analyses, participants will be discharged from the clinical facility on Day 3. On days 4, 6, 8 and 15 participants will return to the clinical facility to attend out-patient visits including safety tests and pharmacokinetics (PK) Days 2 through 25 is a study drug-free period, or daily dosing wash out period (of a minimum 25 days). The minimum period between the completion of Part A (Day 15) and commencement of Part B will be 10 days. A Safety Summary, (consisting of laboratory safety data obtained though Day 6) and pharmacokinetic (PK) data (through Day 6) will be analysed (in blinded manner) for review by the Principal Investigator and Sponsor’s Representative prior to the initiation (dosing) of the multiple dosing part of the study. Part B: Multiple Dose Day 1 starts the multi-dose administration period. Participants will return to the clinic for a pre-dose blood draw and commence daily oral administration of the study drug (one 4mg (Z)-endoxifen tablet or placebo tablet daily) for 14 consecutive days (Part B Days 1 - 14). Participants will be supplied with study drug and instructed to self-administer each morning on an empty stomach (defined as a minimum of 8 hours fasting). Prior to dose administration on Part B Day 7 participants will visit the clinical facility for PK blood draws and safety assessments. Part B Day 14 is the last day of study drug administration. Each participant will return to the clinical facility and check-in on Day 13 prior to final dose administration on Day 14 and will be confined to the facility until Day 16 to allow for the collection of blood for PK and safety assessments. Participants will be discharged from the clinical facility on Day 16 and will return for blood collection for PK and safety assessments on study Days 17, 19, and 21. All study visits (out patient and in-house) will consist of PK and safety assessments.
Sponsors
Atossa Genetics Aus Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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 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. 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.
Outcome results
None listed