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| ID | Type | Description | Link |
|---|---|---|---|
| EUDract No: 2010-019434-27 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD8848 given to BChE deficient subjects and age & gender matched control subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8848 | Drug | Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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. | |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Pharmacodynamics (IL-1Ra in plasma) | Prior to administration of the IP (Day 0) and repeated assessments during the first 48h. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Sonne, MD | DanTrials ApS, Copenhagen, Denmark | Principal Investigator |
| Sam Lindgren, MD, PhD | AstraZeneca R&D, Lund, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Copenhagen | Copenhagen | Denmark |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| C537417 | Butyrylcholinesterase deficiency |
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| ID | Term |
|---|---|
| C000609563 | AZD8848 |
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