Trial | NCT01205867  Report issue

Title

Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects
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 Intranasally to Male and Female Butyrylcholinesterase Deficient Subjects and to Sex and Age Matched Controls

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    azd8848 ...

  • Study Participants

    22
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.
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 Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls
Study Started
Sep 30
2010
Primary Completion
Feb 28
2011
Study Completion
Jan 31
2012
Last Update
Aug 14
2015
Estimate

Drug AZD8848

Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg

1 Experimental

AZD8848 given to BChE deficient subjects and age & gender matched control subjects

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted