None listed
Conditions
Brief summary
This study aims to assess the safety and tolerability of Topical Endoxifen when administered as a topical application to the breast of healthy male volunteers. Who is it for? You may be eligible to join this study if you are a healthy male volunteers aged between 18 and 65 years Study details: This is a double-blind, placebo controlled, dose escalation trial investigating the safety and pharmacokinetics of Topical Endoxifen applied to the breasts of healthy male volunteers. Three dose levels of Topical Endoxifen will be investigated in 3 cohorts. In each cohort, participants will be randomized to receive Topical Endoxifen or placebo in a blinded fashion.
Interventions
Healthy male volunteers will be screened within 28 days prior to commencement of dosing.
Study consists of 3 cohorts, each cohort consisting of 8 participants with 6 participants receiving (Z)-Endoxifen topical and 2 participants receiving placebo topical. Three dose levels of topically applied (Z)-Endoxifen (2mg, 6mg, and 10 mg) will be investigated in the 3 cohorts. Participants will be admitted in the clinical facility on Day-1 and will receive the IMP in pre-sealed sachets for topical appli
Healthy male volunteers will be screened within 28 days prior to commencement of dosing. Study consists of 3 cohorts, each cohort consisting of 8 participants with 6 participants receiving (Z)-Endoxifen topical and 2 participants receiving placebo topical. Three dose levels of topically applied (Z)-Endoxifen (2mg, 6mg, and 10 mg) will be investigated in the 3 cohorts. Participants will be admitted in the clinical facility on Day-1 and will receive the IMP in pre-sealed sachets for topical application on Day 1. They will be discharged on Day 2 and supplied with study drug sachets and asked to self-administer daily one sachet to each of the breast for 28 days. Participants will return to the clinic weekly for PK sampling and assessment, as well as on Days 4, 31, 33 and 35.
Sponsors
Atossa Genetics, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed