Study to investigate the safety and tolerability of AZD8848 in Butyrylcholinesterase deficient subjects
Study identifier:D0540C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Butyrylcholinesterase deficiency
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD8848
Sex
All
Actual Enrollment
22
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Jan 2012
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD8848 given to BChE deficient subjects and age & gender matched control subjects | Drug: AZD8848 Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg |
Contacts
Investigators
Principal Investigator
Jesper Sonne
DanTrials ApS, Copenhagen, Denmark
