PK Study in Adolescents and Young Adults Treated with Glucocorticoids
Research type
Research Study
Full title
A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated with Glucocorticoids
IRAS ID
138665
Contact name
Nicholas Bishop
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
Eudract number
2012-003414-14
Research summary
Odanacatib (MK-0822), the study drug, is being developed for the treatment of postmenopausal osteoporosis (decrease in bone mass and density and that leads to an increased risk of fracture). Glucocorticoid (a hormone) induced osteoporosis is an unfortunate consequence of many treatments for paediatric disorders.
This study is aiming to recruit 12 - 25 year old patients, who are receiving glucocorticoid treatments. Patients will either receive a low dose of the study drug, a higher dose of the study drug or placebo (no active drug present). All three treatments are administered as one oral dose under controlled conditions.
Following the administration of the study drug, various tests including blood and urine tests will be conducted to determine the results for the main objectives of the study - which is to assess the safety and tolerability of this single dose of the study drug and see how the drug acts within the body.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0811
Date of REC Opinion
16 Dec 2013
REC opinion
Favourable Opinion