Status:
UNKNOWN
Nasally and sc Administered Teriparatide in Healthy Volunteers
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
Osteoporosis
Eligibility:
FEMALE
55-90 years
Phase:
PHASE1
Brief Summary
Osteoporosis is a reduction in bone density that increases the risk of fractures; particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million women worldwide - approximat...
Detailed Description
This study aims to look at how teriparatide spreads through the nose and into the blood stream when it is given as a liquid with a nasal delivery system called CriticalSorb™. CriticalSorb has been dev...
Eligibility Criteria
Inclusion
- Be a postmenopausal healthy female and aged greater than 55 years of age
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments
- Be willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
- Be willing to abstain from smoking for 24 hours before each dose and until the end of each study day
- Be willing to avoid caffeine from midnight the evening prior to each study day
Exclusion
- Have a history of alcohol or drug abuse and failure of urine tests for drug abuse
- Have had any investigational drug administered within the previous 3 months.
- Failed to satisfy the investigator's assessment of fitness to participate based on a completed health screening
- Have consumed alcohol or tobacco within 24 hours of start of each study day
- Have consumed caffeinated drink after midnight prior to each study day
- Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)
- Have any presently active infectious diseases (such as influenza)
- Have a known hypersensitivity to teriparatide or to any of the excipients in the formulation
- Have a history of nasal disorders/problems
- Have a history of allergic rhinitis
- Have an increased baseline risk of osteosarcoma
- Have Paget's disease
- Have a history of any malignancy or radiotherapy
- Have a history of diabetes
- Have a history of hypercalcaemia
- Are taking any forbidden medications - see Appendix 2
- Inability to use both of the intranasal delivery devices
- Have a condition that prohibits MRI scans
- Have positive HIV or Hepatitis B or C test results or engage in a lifestyle that increases the risk of the possibility of these infections
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01913834
Start Date
September 1 2013
End Date
August 1 2014
Last Update
August 1 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH