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Study Complete
Sponsor ID
20101131

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

Sponsor ID
20101131
Clinicaltrials.gov ID
NCT01221727
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
30
Additional Study Details

Protocol Summary

Primary Outcome Measures

The area under the serum concentration-time curve and maximum observed concentration for midazolam from subjects who receive denosumab administration.

Timeframe: A total of 47 days following investigational product administration.

Secondary Outcome Measures

Additional midazolam pharmacokinetic (PK) parameters (eg, time of maximum drug concentration, half-life).

Timeframe: A total of 47 days following investigational product administration.

The serum denosumab and serum C-telopeptide concentrations.

Timeframe: A total of 47 days following investigational product administration.

The area under the serum concentration-time curve and maximum observed concentration for midazolam from subjects who only receive midazolam administration.

Timeframe: A total of 47 days following investigational product administration.

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
45 - 75 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Nov 2010 - Jul 2011
    Inclusion and Exclusion 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