MedTrace Logo

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

NCT01630616 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-08-28

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Odanacatib

single oral dose, tablets, 10 or 50 mg

DRUG

Placebo

single oral dose, tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-12
Primary Completion
2016-07-14
Completion
2016-07-14
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630616 on ClinicalTrials.gov