A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)
Status: | Recruiting |
---|---|
Conditions: | Osteoporosis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 12 - 25 |
Updated: | 8/5/2016 |
Start Date: | March 2013 |
End Date: | June 2018 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids
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.
single doses of odanacatib in mature adolescents and young adults who are currently
receiving glucocorticoid therapy.
Inclusion Criteria:
- Female subjects 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
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