Overview

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