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

September 20, 2010
January 16, 2012
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) ] [ 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 ]
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. ] [ 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 ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01205867
D0540C00009, EUDract No: 2010-019434-27
No
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
January 2012

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