A Phase I, Randomised, Double-Blinded, Placebo Controlled, Safety and Pharmacokinetic Study of (Z)-Endoxifen Tablets in Healthy Female Volunteers

Phase 1

Completed

• Conditions: Estrogen Receptor Positive (ER+) Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12619001623189
• Lead Sponsor: Atossa Genetics Aus Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-22
• Study Completion: 2020-02-18
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified