Status:
COMPLETED
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus Type 2
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of A...
Eligibility Criteria
Inclusion
- Provision of signed written and dated informed consent
- BMI between 19 and 30 kg/m2
- Subjects must be willing to use barrier methods of contraception
Exclusion
- History of any clinically significant disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Laboratory blood sample result showing elevated liver enzymes (ASAT, ALAT) and muscle enzymes (CK).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00841048
Start Date
February 1 2009
End Date
May 1 2009
Last Update
September 30 2009
Active Locations (1)
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1
Research Site
Gothenburg, Sweden