osteoporosis MedDRA version: 14.1 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Odanacatib
Product Code: MK-0822
Pharmaceutical Form: Tablet
INN or Proposed INN: Odanacatib
CAS Number: 603139-19-1
Current Sponsor code: MK-0822
Concentration unit: mg milligram(s)
Con
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The parent or guardian and subject agrees to the subject’s participation in the study as indicated by parental/guardian signature on the consent form and subject assent. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. . a Written assent will be sought from subjects of appropriate intellectual maturity. The subject is willing to comply with procedures, and is able to keep scheduled clinic visits. 2)The subject is a male or female between the ages of 12 and 18 years of age (inclusive) on the day of screening. 3) Female subjects of reproductive potential (or other female subjects at the discretion of the investigator) must demonstrate a serum ß-hCG level consistent with the nongravid state at the prestudy (screening) visit 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. Acceptable methods of birth control are two (2) of the following: intrauterine device (IUD without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and /or condoms. Abstinence is an alternative life style and subjects practicing abstinence may be included in the study. 4) Subject is currently receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period when pharmacokinetic and pharmacodynamic determinations are being made. Subject must have started glucocorticoid therapy at least approximately 3 month prior to study drug administration. The dose of glucocorticoids should be equivalent =5 mg/day of prednisone, other glucocorticoids may be allowable at the discretion of the investigator after consultation with the SPONSOR medical monitor. 5) Subject has radiographic evidence of closed epiphyses at the hand 6) Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening). 7) Subject is a nonsmoker. 8) Subject is willing to comply with the study restrictions (see Section 3.2 for a complete summary of study restrictions). Are the trial subjects under 18? yes Number of subjects for this age range: 16 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Subject or parent/legal guardian, is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator. b. Female subject has a positive pregnancy test within 24 hours of study initiation or an unwillingness to undergo pregnancy testing. c. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study. d. Subject has an estimated creatinine clearance of = 80 mL/min based on the Schwartz equation; the Schwartz equation is: CrCl (mL/min) = [length (cm) × k]/SCr (mg/dL), where k = 0.55 for females age 12 to 18 years, and k = 0.7 for males age 12 to 18 years. An actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of, or in conjunction with, the Schwartz equation. e. Subject’s blood pressure is >95th percentile for age and gender (see Attachment 3: Pediatrics, Vol. 98, No. 4; 1996). Subjects with transient/intermittent blood pressure readings >95th percentile for age and gender may be enrolled at the discretion of the investigator. f. Subject has a history of stroke, chronic seizures, or major neurological disorder. g. Subjects with a history of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the investigator. h. Subject has a history of malignant neoplastic disease. i. Subject is a nursing mother. j. Subject has a serum calcium level obtained at screening that is below the lower limit of normal. k. The subject has any clinically significant primary growth disorder (e.g., achondroplasiaor growth hormone deficiency). l. The subject has any disease affecting the stomach or proximal small intestine resulting in malabsorption. m. Prior to screening the subject received treatment which might have influenced bone turnover, including: 1) Within 6 months: anabolic steroids (including DHEA and other weaker analogs), testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A (>10,000 units/day) or excess vitamin D (>3000 units/day), or cyclosporine. 2) Within 6 months: initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing products. 3) Thyroid hormone (levothyroxine, L-T4), unless on a stable dose for at least 3 months before screening, and has a normally functioning thyroid gland (is euthyroid) as documented by an ultrasensitive thyroid stimulating hormone (TSH) serum assay conducted at screening that is within the normal range. 4) Previous treatment with any marketed or experimental bisphosphonate within the 12 months preceding screening visit. n. The subject has, within 3 years prior to screening, a 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. o. The subject has a history of, or evidence for, hypothyroidism, unless the subject has been trea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of single doses of odanacatib in mature adolescents. Compare plasma pharmacokinetic parameters[AUC0-8, AUC0-168hr, Cmax, C168hr, Tmax, apparent terminal t1/2] following single oral doses of odanactib 10mg and 50mg between mature adolescents and healthy adult historical controls. ;Secondary Objective: To assess effects of single oral doses of odanacatib 10 and 50 mg on urinary amnioterminal crosslinked telpeptide of Type I collagen, in mature adolescents treated with glucocorticoids. The PK/PD relationship between concentration and inhibition of uNTx/Cr levels for odanacatib in adolescents treated with glucocorticoids will be evaluated and the relationship to that seen in adults will be examined. ;Primary end point(s): Number of Participants who Report an Adverse Event, Area under the concentration time curve from 0 hour to infinity( AUC0-8) , Area under the concentration time curve from 0 hour to 168hr of Odanacatib (AUC0-168hr, ) Maximum Plasma Concentration of odanacatib (Cmax, ) Plasma Concentration at 168hours (C168hr, ) Time to Cmax of odanacatib (Tmax, ) apparent terminal t1/2 of odanacatib ;Timepoint(s) of evaluation of this end point: up to day 14(AEs) Hour 0 (predose) and at 1, 2, 6, 12, 24, 72, 120, 168, 240 and 336 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in inhibition of urinary aminoterminal crosslinked telopeptide of Type 1 collagen (uNTx/Cr);Timepoint(s) of evaluation of this end point: Baseline (predose Day 1) and 168 hours post dose | — |
Countries
Canada, United States
Contacts
Public ContactAubrey Stoch
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
Outcome results
None listed