A Study of Axiron® in Healthy Participants
Condition: Healthy Volunteers
Intervention: Axiron
Intervention description: Solution administered topically using pump and applicator
Intervention MeSH terms: Testosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves application of Axiron to each underarm. The study will evaluate the
      transfer of testosterone from underarms to the clothing items that the participant is wearing
      and other fabric items washed with participant's' clothes. The study is approximately 6 days,
      not including screening. Screening is required within 28 days prior to the start of the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males, as determined by medical history and physical examination,
             or males who have been on stable medication for at least 1 month and have no
             significant clinical conditions.

          -  Agree to use a reliable method of birth control (for example: condom or vasectomy)
             during the study and for 3 months following the Axiron dose

          -  Have clinical laboratory test results within the normal reference range for the
             population or investigator site, or results with acceptable deviations that are judged
             to be not clinically significant by the investigator

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or
             off-label use of a drug or device, or are concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Are participants who have previously completed or withdrawn from this study or any
             other study investigating Axiron in the past 3 months

          -  Have known allergies to testosterone solution, related compounds, or any components of
             the formulation, or history of significant atopy

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure as determined by the investigator

          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders constituting a
             risk when taking the study medication or that could interfere with the interpretation
             of the data

          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for
             basal cell or squamous epithelial carcinomas of the skin that have been resected with
             no evidence of metastatic disease for 3 years

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  Use of any topical testosterone replacement therapy within the 3 months prior to study
             entry through study discharge, except for use of Axiron as directed by study
             procedures

          -  Use of parenteral testosterone replacement (testosterone enthanate, testosterone
             cypionate) within the 30 days prior to screening. Use of long acting intramuscular
             testosterone undecanoate 6 months prior to screening, or use of testosterone pellets
             12 months prior to screening

          -  Have a dermatologic condition in the underarm area that might be exacerbated by
             topical testosterone replacement therapy, in the opinion of the investigator

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study