drugset / Trial / NCT01630616

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

NCT01630616

Phase 1 Terminated 19 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-03-12
Primary completion
2016-07-14
Completion
2016-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Odanacatib Small molecule 10 mg Oral
Subject Odanacatib Small molecule 50 mg Oral

Indications