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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01205867
First received: September 20, 2010
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Butyrylcholinesterase Deficiency
 Drug: AZD8848
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Pharmacodynamics (IL-1Ra in plasma) [ Time Frame: Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8848 given to BChE deficient subjects and age & gender matched control subjects
 Drug: AZD8848
Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205867

Locations
Denmark
Research Site
Copenhagen, Denmark
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jesper Sonne, MD DanTrials ApS, Copenhagen, Denmark
Study Director: Sam Lindgren, MD, PhD AstraZeneca R&D, Lund, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01205867     History of Changes
Other Study ID Numbers: D0540C00009, EUDract No: 2010-019434-27
Study First Received: September 20, 2010
Last Updated: January 16, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:
Butyrylcholinesterase deficiency
tolerability
safety
AZD8848
 pharmacokinetics
pharmacodynamics
BChE deficient subjects and matched control subject

Additional relevant MeSH terms:
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013