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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Midazolam

Criteria

Inclusion Criteria:

• Between 45 to 75 years of age

• Postmenopausal women

• Osteoporosis

Exclusion Criteria:

• Use of any known inhibitors of cytochrome P450 3A4/P-gp (CYP3A4) within 14 days or 5 half lives, whichever is longer; or grapefruit juice or grapefruit containing products within 7 days prior to investigational product administration

• Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer, prior to investigational product administration

• Use of any herbal medicine with a known impact on CYP3A4 (eg, St. John's wort) within 30 days prior to investigational product administration

• Current use of medications prescribed for osteoporosis treatment

• Use of midazolam within 14 days prior to investigational product administration

• Influenza or other vaccination within 28 days of screening

• Previous exposure to denosumab