A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)

This study is currently recruiting participants.
Verified March 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01630616
First received: June 26, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Odanacatib
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants who Report an Adverse Event (AE) [ Time Frame: Up to Day 14 ] [ Designated as safety issue: Yes ]
  • Area Under the Concentration Time Curve from hour 0 to infinity (AUC0-inf) of Odanacatib [ Time Frame: Hour 0 (predose), and at 1, 2, 6, 12, 24, 72, 120, 168, 240, and 336 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Concentration Time Curve from 0 to 168 hours (AUC0-168) of Odanacatib [ Time Frame: 0 (predose), and at 1, 2, 6, 12, 24, 72, 120, 168, 240, and 336 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of Odanacatib [ Time Frame: 0 (predose), and at 1, 2, 6, 12, 24, 72, 120, 168, 240, and 336 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Cmax (Tmax) of Odanacatib [ Time Frame: 0 (predose), and at 1, 2, 6, 12, 24, 72, 120, 168, 240, and 336 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent terminal half-life (t1/2) of Odanacatib [ Time Frame: 0 (predose), and at 1, 2, 6, 12, 24, 72, 120, 168, 240, and 336 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Inhibition of urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) [ Time Frame: Baseline (predose Day 1) and 168 hours postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib 10 mg Drug: Odanacatib
single oral dose, tablets, 10 or 50 mg
Other Name: MK-0822
Experimental: Odanacatib 50 mg Drug: Odanacatib
single oral dose, tablets, 10 or 50 mg
Other Name: MK-0822
Placebo Comparator: Placebo Drug: Placebo
single oral dose, tablets

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, Thyroid hormone, unless on a stable dose for at least 3 months, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630616

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Connecticut
Call for Information (Investigational Site 0001) Recruiting
New Haven, Connecticut, United States, 06510-8047
United States, Indiana
Call for Information (Investigational Site 0002) Recruiting
Indianapolis, Indiana, United States, 46202
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Cem Ozesen    90 212 3361260      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01630616     History of Changes
Other Study ID Numbers: 0822-066
Study First Received: June 26, 2012
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014