A phase I, placebo controlled, dose escalation safety andpharmacokinetic study of Topical Endoxifen in healthy male volunteers.
- Conditions
- GynecomastiaMetabolic and Endocrine - Other endocrine disorders
- Registration Number
- ACTRN12618000569202
- Lead Sponsor
- Atossa Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 24
1. Healthy adult males, 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,
4. Medically healthy without clinically significant abnormalities at the screening visit or Day -1,
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
8. Participants with partners of child-bearing potential must agree to use condom and one
of the following contraceptive methods:
a. Complete abstinence from intercourse during the dosing with study drug through the End-of-Study and at least 60 days after the conclusion of study drug administration; OR
b. The female partner must be using effective contraception such as hormonal, IUD, a double-barrier method, or is sterilized; OR
c. Sterilization (vasectomy);
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.
1. History or presence of a clinically significant disorder including but not limited to: cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric or neurological disease, including any acute
illness or surgery within the past three months determined by the PI to be clinically relevant;
2. History of drug addiction, including alcohol within 1 year;
3. Smokes or uses e-cigarettes;
4. Have a hypersensitivity or allergy to the investigational compound;
5. Treatment, within 3 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
6. Have participated in any other investigational study within 30 days or 5 half-lives of the drug (whichever is longer) of screening;
7. 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;
8. Have any history or evidence of procoagulant disorder, Deep Vein Thrombosis (DVT) or pulmonary embolism;
9. 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.
10. Any conditions, that according to investigator's best judgment, prevent participation in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of (Z)-endoxifen when administered topically to the breast of healthy male volunteers and will include recording the incidence and severity of adverse events, vital sign parameters, physical examination findings, electrocardiogram parameters and clinical laboratory parameters (serum chemistry, hematology, coagulation, urinalysis).[The safety assessments mentioned above are composite primary outcome and will be done at each of the visits, weekly for a month and on days 4, 31, 33 and 35.<br>The blood pressure and pulse will be assessed by pulse oximetry while respiratory rate, physical examination will be assessed clinically. Temperature will be assessed by using a tympanic thermometer while an ECG will be recorded by an instrument which involves the placement of electrodes on the chest wall.<br>Blood will be collected for hematology, coagulation and clinical chemistry lab assessments while urine will be collected for urinalysis.]
- Secondary Outcome Measures
Name Time Method Assess the side effects associated with (Z)-endoxifen treatment using the modified FACT-ES questionnaire. [To be performed on Day 1, Day 7, Day 14, Day 21, Day 28 and Day 35.];To assess the pharmacokinetics of multiple doses of (Z)-endoxifen when administered topically to the breast of healthy male volunteers.<br>Pharmacokinetic parameters which will be assessed include Cmax, Tmax, AUC0-24h, t1/2[Blood sampling for pharmacokinetic analysis will be performed at Day 1, Day 4, Day 7, Day 14, Day 21, Day 28, Day 29, Day 31, Day 33 and Day 35.]