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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Butyrylcholinesterase Deficiency

Treatments: Drug: AZD8848

Study type: Interventional

Funder types: Industry

Identifiers

NCT01205867

D0540C00009

EUDract No: 2010-019434-27

Details and patient eligibility

About

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.

Full 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 Intranasally to Male and Female Butyrylcholinesterase deficient Subjects and to Sex and Age matched Controls

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: AZD8848