CompletedPhase 1

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

Denmark22 participantsStarted 2010-09

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: Repeated assessments during Day 2.

Trial details

NCT IDNCT01205867

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Butyrylcholinesterase Deficiency trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: Repeated assessments during Day 2.