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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205867
First Posted: September 21, 2010
Last Update Posted: August 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
September 20, 2010
September 21, 2010
August 14, 2015
September 2010
February 2011   (Final data collection date for primary outcome measure)
  • 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. ]
Same as current
Complete list of historical versions of study NCT01205867 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient 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
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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Butyrylcholinesterase Deficiency
Drug: AZD8848
Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
Experimental: 1
AZD8848 given to BChE deficient subjects and age & gender matched control subjects
Intervention: Drug: AZD8848
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2012
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01205867
D0540C00009
EUDract No: 2010-019434-27
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Jesper Sonne, MD DanTrials ApS, Copenhagen, Denmark
Study Director: Sam Lindgren, MD, PhD AstraZeneca R&D, Lund, Sweden
AstraZeneca
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP