Butyrylcholinesterase Deficiency Clinical Trial
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
| Verified date | August 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | January 2012 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Research Site | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Immediately prior to administration of the IP (Day 0) | No | |
| Primary | 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 | Repeated assessments during Day 1. | No | |
| Primary | 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 | Repeated assessments during Day 2. | No | |
| Secondary | Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine) | Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. | No | |
| Secondary | Pharmacodynamics (IL-1Ra in plasma) | Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. | No |