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Completed

NCT Number: NCT01205867

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

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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Key information

Conditions

Butyrylcholinesterase Deficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Copenhagen, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8848

Drug

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

Primary outcomes

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

  2. 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.

  3. 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

  1. 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.

  2. Pharmacodynamics (IL-1Ra in plasma)

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 21, 2010
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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