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

NCT ID: NCT01630616

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-12
• Study Completion Date: 2016-07-14

Brief 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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adolescents Odanacatib 10 mg

Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.

Group Type: EXPERIMENTAL

Odanacatib

Intervention Type: DRUG

single oral dose, tablets, 10 or 50 mg

Adolescents Odanacatib 50 mg

Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.

Group Type: EXPERIMENTAL

Odanacatib

Intervention Type: DRUG

single oral dose, tablets, 10 or 50 mg

Adolescents Placebo

Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single oral dose, tablets

Young Adults Odanacatib 50 mg

Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.

Group Type: EXPERIMENTAL

Odanacatib

Intervention Type: DRUG

single oral dose, tablets, 10 or 50 mg

Young Adults Placebo

Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single oral dose, tablets

Interventions

Odanacatib

single oral dose, tablets, 10 or 50 mg

Intervention Type: DRUG

Placebo

single oral dose, tablets

Intervention Type: DRUG

Other Intervention Names

MK-0822

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-0822-066

Identifier Type: OTHER

Identifier Source: secondary_id

0822-066

Identifier Type: -

Identifier Source: org_study_id