Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT01221727
First received: October 14, 2010
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Postmenopausal Osteoporosis
 Drug: Denosumab
Drug: Midazolam
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam, a Cytochrome P450 3A4/P-gp (CYP3A4) Substrate, in Postmenopausal Osteoporotic Women

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The area under the serum concentration-time curve and maximum observed concentration for midazolam from subjects who receive denosumab administration. [ Time Frame: A total of 47 days following investigational product administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional midazolam pharmacokinetic (PK) parameters (eg, time of maximum drug concentration, half-life). [ Time Frame: A total of 47 days following investigational product administration. ] [ Designated as safety issue: No ]
  • The serum denosumab and serum C-telopeptide concentrations. [ Time Frame: A total of 47 days following investigational product administration. ] [ Designated as safety issue: No ]
  • The area under the serum concentration-time curve and maximum observed concentration for midazolam from subjects who only receive midazolam administration. [ Time Frame: A total of 47 days following investigational product administration. ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Midazolam
All 27 subjects will receive midazolam.
 Drug: Denosumab
Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.
Active Comparator: Denosumab
Eighteen (18) subjects will receive denosumab.
 Drug: Midazolam
All subjects will receive two oral dose administrations of midazolam.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221727

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT01221727     History of Changes
Other Study ID Numbers: 20101131
Study First Received: October 14, 2010
Last Updated: September 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
Phase 1
Postmenopausal
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013