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

Phase 1CompletedNCT01205867

AstraZeneca22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Butyrylcholinesterase Deficiency

Interventions

AZD8848DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Copenhagen, Copenhagen, Denmark

Outcomes

Primary Outcomes

Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose

Time frame: Immediately prior to administration of the IP (Day 0)

Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose

Time frame: Repeated assessments during Day 1.

Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose

Time frame: Repeated assessments during Day 2.

Secondary Outcomes

Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)

Time frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.

Pharmacodynamics (IL-1Ra in plasma)

Time frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.

Data from ClinicalTrials.gov

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