The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam

Status Completed

Clinical Trial Summary

This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

Clinical Trial Description

Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to determine the effect of denosumab on the PK of midazolam will be based on data from subjects in Group A only. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01221727
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 1
Start date	November 2010
Completion date	July 2011

View Details

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