Status:
COMPLETED
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Butyrylcholinesterase Deficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects in comparison with sex and age matched control subjects.
Detailed Description
An Open, Non-controlled, Non-randomised, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD 8848 Administered Intranas...
Eligibility Criteria
Inclusion
- BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test
- Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test
Exclusion
- Any clinically relevant abnormal findings in physical examination, laboratory assessments, vital signs or ECG
- Present or medical history of cardiovascular disease which, in the opinion of the investigator, may either put subject at risk because of participation in the study or influence the result of the study or the subject's ability to participate in the study
- Family history of autoimmune disease
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01205867
Start Date
September 1 2010
End Date
January 1 2012
Last Update
August 14 2015
Active Locations (1)
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1
Research Site
Copenhagen, Copenhagen, Denmark