A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole

NCT03314298 | Completed Phase 1 DMC

• 1 other identifier: HAV-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women

Conditions

Mammographic Density

Outcome Measures

Primary Outcomes (6)

• testosterone Cmax

  Peak Plasma Concentration

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

• testosterone AUC

  Area under the plasma concentration versus time curve

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

• testosterone T1/2

  plasma half-life

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

• anastrozole Cmax

  Peak Plasma Concentration

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

• anastrozole AUC

  Area under the plasma concentration versus time curve

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

• anastrozole T1/2

  plasma half-life

  Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The outcome measures will be reported weekly until study completion-3 months

• dihydrotestosterone metabolism

  3 months

• breast elasticity

  Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85

Study Arms (1)

testosterone anastrozole implant

EXPERIMENTAL

testosterone 80mg Anastrozole 4 mg single as a subcutaneous pellet

Drug: testosterone anastrozole

Interventions

testosterone anastrozole DRUG

subcutaneous testosterone and anastrozole

Also known as: testosterone, anastrozole

testosterone anastrozole implant

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agree to and be capable of understanding and signing an Informed Consent Form.
• Patients seeking treatment with Investigational Product for the reduction in high mammographic breast density (MBD).
• Pre-menopausal levels of Follicular stimulating hormone/Leutinizing hormone/estradiol(follicle stimulating hormone/luteinizing hormone/oestrogen) according to the definition of "pre-menopausal range" for the laboratory involved.
• Volpara Density volumetric breast density of ≥15.5% (combined average both breasts)
• Age between 35-55 years inclusive.
• Body weight between 50-90 kg inclusive.
• BMI between 20-30 kg/m2 inclusive.
• Good venous access for venepuncture.
• In good general health without clinically significant cardiac, respiratory, or psychiatric disease.
• Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilisation), no more than seven days before the first dose of Investigational Product.
• For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception (Mirena (TM) allowed) during and for at least six months after completion of treatment with Investigational Product; OR, a fertile male partner willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilisation) during and for at least six months after completed dosing Investigational Product.

You may not qualify if:

• Presence of breast cancer.
• Previous or concomitant other malignancy (non-breast, other than skin) within the previous five years.
• Diabetes mellitus or glucose intolerance defined as a fasting glucose of ≥ 6 mmol/L.
• History of coronary artery disease.
• Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood.
• Existing testosterone, oestrogen and/or anastrozole treatment.
• Concomitant medication which induces or inhibits CYP3A4 (Listed in Appendix A).
• Current warfarin usage.
• Prolonged systemic corticosteroid treatment, inhalation and topical steroids allowed.
• Known hypersensitivity to any component of Investigational Product.
• Systemic reproductive hormone replacement therapy.
• Systemic hormonal contraception.
• Participation in another clinical trial of an Investigational Product within 30 days of entry into the present trial or within 4-5 half-lives of the Investigational Product, whichever is the longer.
• Use of any product containing ginseng within 30 days of screening.
• Pregnant or lactating women.

Sponsors & Collaborators

• Havah Therapeutics Pty Ltd: lead

Study Sites (1)

Wellend Health

Toorak Gardens, South Australia, 5065, Australia

Location

MeSH Terms

Interventions

Testosterone; Anastrozole

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephen N Birrell, Md PhD

  Wellend Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open labelled pharmacokinetic study

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: October 19, 2017
• Study Start: August 14, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: April 18, 2018

Record last verified: 2017-10

Locations

AU (1)