Clinical trial NCT01630616: A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)
Official title: A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Who Report an Adverse Event (AE)
timeFrame: Up to Day 14
measure: Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose
measure: Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
measure: Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
timeFrame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
Secondary outcomes:
measure: Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose
timeFrame: Baseline (predose Day 1) and 168 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: