Status:
TERMINATED
AZD5985 Single Ascending Dose Study
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.
Eligibility Criteria
Inclusion
- Provision of signed, written and dated informed consent prior to any study specific procedure
- Healthy male subjects aged 18 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start
Exclusion
- History or presence of any clinically significant disease or disorder in the opinion of the investigator
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
- Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00967356
Start Date
August 1 2009
End Date
November 1 2009
Last Update
November 13 2009
Active Locations (1)
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1
Research Site
Gothenburg, Sweden