PK Study in Adolescents and Young Adults Treated with Glucocorticoids
- Conditions
- OsteoporosisMedDRA version: 18.1Level: PTClassification code 10031282Term: OsteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2012-003414-14-FI
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 19
Consent/Assent for Panels A and B only:
1. The parent or guardian and subject agree 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.
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.
Or
Consent for Panel C only:
1. The subject is willing to give written informed consent to participate in the trial.
2. The subject is a male or female between the ages of 12 and 17 years of age (inclusive) on the day of screening for Panels A and B only. The subject is a male or female between the ages of 18-25 years of age (inclusive) on the day of screening for Panel C only.
3. Female subjects of reproductive potential (or other female subjects at the discretion of the investigator) must demonstrate a serum or urine 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 (screening) visit throughout the study and until 2 weeks after administration of the study drug. Acceptable methods of birth control are as follows:
Females of childbearing potential can be enrolled. However, two (2) acceptable methods of barrier contraception must be used beginning at the prestudy visit, throughout the study and until 2 weeks after the dose of study drug. Acceptable methods of birth control are two (2) of the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, and/or condoms. OR use appropriate double barrier contraception as per local regulations or guidelines. Abstinence is an alternative life style and subjects practicing abstinence may be included in the study.
Alternatively, women may use an appropriate hormonal contraception instead of one of the two barrier methods. Appropriate hormonal contraception may include any marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, transdermal, intrauterine, or intramuscular agents). If hormonal contraception is used as one of the methods, hormonal contraceptives must have been used for at least 2 months prior to administration of trial drug for subjects to be eligible for enrollment into the trial.
4. Subject is currently receiving glucocorticoid therapy and will be at a dose anticipated to be stable over the course of the study period starting 1 week prior to Day 1, through the poststudy visit. Subject must have started glucocorticoid therapy at least approximately 1 month prior to study drug administration. The dose of glucocorticoids should be = 4.5 mg/day of prednisone or equivalent, other glucocorticoids may be allowable at the discretion of the investigator after consultation with the SPONSOR medical monitor.
5. Subject (Panels A and B; Panel C at the discretion of the investigator and Sponsor) has radiographic evidence of closed epiphyses at the hand as confirmed by an independent reviewer (i.e., central vendor).
6. Subject is willing to comply with the study restrictions (see Section 3.2 for a complete summary of study res
1. 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.
2. Female subject has a positive pregnancy test within 24 hours of study drug administration or an unwillingness to undergo pregnancy testing.
3. 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.
4. For Panels A and B only, 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 17 years, and k = 0.7 for males age 12 to 17 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.
For Panel C only, subject has an estimated creatinine clearance of =80 mL/min based on the Cockcroft-Gault equation; the Cockcroft-Gault equation is:
ClCr = (140-age[yr])(body wt [kg])
(72)(serum creat [mg/dL])
When creatinine is measured in micromole/litre, use the following formula:
ClCr = (140-age[yr])(body wt[kg])
(72)(serum creatinine [micromol/L] x 0.0113)
An actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of, or in conjunction with, the Cockcroft-Gault equation; subjects who have an actual or estimated creatinine clearance up to 10% below 80 mL/min may be enrolled in the study at the discretion of the investigator.
5.Subject’s blood pressure is >95th percentile for age and gender.
Subjects with transient/intermittent blood pressure readings >95th percentile for age and gender may be enrolled at the discretion of the investigator.
6. Subject has a history of malignant neoplastic disease.
7. Subject is a nursing mother.
8. Subject has a serum calcium level obtained at screening that is below the lower limit of normal.
9. The subject has any clinically significant primary growth disorder (e.g., achondroplasia or growth hormone deficiency).
10. The subject has any disease affecting the stomach or proximal small intestine resulting in malabsorption.
11. Prior to screening the subject received treatment which might have influenced bone turnover, including:
a)Within 6 months of screening: 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).
b) Within 3 weeks of screening, cyclosporine.
c)Thyroid hormone (levothyroxine, L-T4). However, if on a stable dose for at least 1 month before dosing, and has thyroid hormone parameters (TSH and/or T3 or FT4) within the reference range at screening, the subject may be allowed to participate after discussion with the SPONSOR medical monitor.
d)Previous treatment with any marketed or experimental bisphosphonate within the 3 months preceding the screening visit.
l2.The subject has, within 3 years prior to screening, a history of, or evidence for, a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method