A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Odanacatib; Placebo
Intervention description: single oral dose, tablets, 10 or 50 mg; single oral dose, tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of
      single doses of odanacatib in mature adolescents and young adults who are currently receiving
      glucocorticoid therapy. The primary hypotheses for the study are that a single dose of
      odanacatib is well tolerated in mature adolescents and following single dose administration
      of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature
      adolescents and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants of reproductive potential (or other female subjects at the
             discretion of the investigator) must have negative serum pregnancy test and agree to
             use (and/or have their partner use) two (2) acceptable methods of birth control
             beginning at the prestudy visit throughout the study and until 2 weeks after the dose
             of study

          -  Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of
             the study period

          -  X-ray evidence of closed epiphyses (growth plate) at the hand

          -  Nonsmoker

        Exclusion Criteria:

          -  Pregnant or unwilling to undergo pregnancy test

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of malignant neoplastic disease (cancer)

          -  Breastfeeding

          -  Primary growth disorder

          -  Any disease affecting the stomach or proximal small intestine resulting in
             malabsorption

          -  Received treatment which might have influenced bone turnover, including anabolic
             steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or
             excess vitamin D, or cyclosporine or initiation of use of birth control pills
             (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen
             containing medications, or thyroid hormone unless on a stable dose for at least 1
             month and has a normally functioning thyroid gland

          -  Previous treatment with any marketed or experimental bisphosphonate within 12 months

          -  History of, or evidence for, any clinically relevant metabolic bone disease (other
             than glucocorticoid-induced bone loss) including but not limited to primary
             hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and
             osteogenesis imperfecta within previous 3 years

          -  History of hypothyroidism

          -  Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic
             beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125
             mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day

          -  Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other
             caffeinated beverages per day

          -  Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or
             participated in another investigational study within 4 weeks

          -  History of significant multiple and/or severe allergies (including latex allergy), or
             has had an anaphylactic reaction or significant intolerability to prescription or
             non-prescription drugs or food

          -  Regular user (including "recreational use") of any illicit drugs, or has a history of
             drug or alcohol abuse

          -  Unable to swallow tablets