NCT01221727

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

The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam, a Cytochrome P450 3A4/P-gp (CYP3A4) Substrate, in Postmenopausal Osteoporotic Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab	Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.
DRUG	Midazolam	All subjects will receive two oral dose administrations of midazolam.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-10-15
• Last updated: 2018-08-07
• Results posted: 2013-11-07