Conditions: Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. arm 2: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. arm 3: Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. arm 4: Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. arm 5: Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.

Interventions: intervention 1: Odanacatib intervention 2: Placebo
Intervention descriptions: intervention 1: single oral dose, tablets, 10 or 50 mg intervention 2: single oral dose, tablets

Protocol document: