Status:
COMPLETED
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Lead Sponsor:
Amgen
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Between 45 to 75 years of age
- Postmenopausal women
- Osteoporosis
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01221727
Start Date
November 1 2010
End Date
July 1 2011
Last Update
August 7 2018
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