Status:
COMPLETED
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male vo...
Eligibility Criteria
Inclusion
- Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
- Pre-dose assessment judged without remarks by the investigator
- Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg
Exclusion
- After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
- Systolic blood pressure (BP) \>140 mm Hg.·
- Diastolic BP \>90 mm Hg.
- Heart rate \<=55 or \>85 beats per minute
- Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference \> 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
- Lack of a normal phenotype for butyrylcholinesterase (pseudo-cholinesterase)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00918515
Start Date
May 1 2009
End Date
August 1 2009
Last Update
August 28 2009
Active Locations (1)
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1
Research Site
Stockholm, Sweden