Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Butyrylcholinesterase Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

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

Interventions

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AZD8848

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes