Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
Condition: Healthy Volunteer
Intervention: Denosumab
Intervention description: 60 mg
Intervention MeSH terms: Denosumab
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12
      healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects
      will be followed by a 105 day treatment-free follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject has provided informed consent; Healthy male between ≥40 to ≤ 65 years of age
        (inclusive) at the time of enrollment; Subject must be willing and able to produce a semen
        sample on seven separate study visits; Subject must be willing to refrain from ejaculation
        for a 48 hour period prior to each sample collection;

        Exclusion Criteria:

        Any condition or drug therapy that might interfere with the subjects ability to ejaculate
        and produce a semen sample; Clinically significant abnormality during the screening
        physical examination, ECG, or laboratory evaluation; Known history of blood in urine or
        semen; Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental
        procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor
        oral hygiene, periodontal and/or pre-existing dental disease; Recent tooth extraction
        (within 6 months of screening visit); Evidence of hypocalcemia at screening; Known vitamin
        D deficiency; Malignancy (except non-melanoma skin cancers) within the last 5 years;
        Positive for human immunodeficiency virus (HIV) at screening or known diagnosis of AIDS;
        Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or
        detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) at
        screening (indicative of active Hepatitis C - screening is generally done by Hepatitis C
        Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive); History
        of hypersensitivity or allergic reaction to mammalian cell derived drug products or
        sensitivity to any of the products or components to be administered during dosing; Known
        intolerance to calcium or vitamin D supplements; Subject previously has entered this study
        or has been previously exposed to denosumab in the past 12 months; Has donated or lost ≥
        400 mL of blood or plasma within 8 weeks prior to screening; Positive urine screen for
        alcohol and/or potential drugs of abuse at screening unless medication is prescribed by a
        physician and approved by the Investigator and Amgen; Known alcohol abuse or use of illicit
        drugs within 12 months of enrollment; Subject is unwilling or unable to limit alcohol
        consumption throughout the course of the study. Alcohol is prohibited 24 hours prior to
        screening and administration of investigational product. Alcohol is limited to no more than
        2 drinks per day for the duration of the study; where a standard drink is equivalent to 12
        ounces of regular beer, 8-9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80
        proof distilled spirits; Currently receiving treatment in another investigational device or
        drug study, or less than 30 days or 5 half-lives (whichever is longer) since ending
        treatment on another investigational device or drug study(s). Other investigational
        procedures while participating in this study are excluded; Use of any non-Amgen approved
        over-the-counter or prescription medications, within the 14 days or 5 half-lives (whichever
        is longer), prior to receiving the dose of denosumab. Acetaminophen (up to 2 g per day) for
        analgesia and hormone replacement therapy (eg, androgen, thyroid) will be allowed. Other
        medications may be approved following review by the Principal Investigator and the Amgen
        Medical Monitor. Written documentation of this review and Amgen acknowledgement is required
        for subject participation; Subject likely to not be available to complete all
        protocol-required study visits or procedures, and/or to comply with all required study
        procedures to the best of the subject and Investigator's knowledge; Subject has any kind of
        disorder that, in the opinion of the Investigator, may compromise the ability of the
        subject to give written informed consent and/or to comply with all required study
        procedures; History or evidence of any other clinically significant disorder, condition or
        disease that, in the opinion of the Investigator or Amgen physician, if consulted, would
        pose a risk to subject safety or interfere with the study evaluation, procedures or
        completion