Status:
COMPLETED
A Study Conducted Over 3 Periods to Look at the Drug in the Body
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A study conducted over 3 periods to look at the drug in the body.
Eligibility Criteria
Inclusion
- Provision of signed and dated written informed consent before any study specific procedures including consent for genetic research exploring genetic variations in CYP3A5
- suitable veins for cannulation or repeated venepuncture
- Subjects should have a body mass index (BMI) between 18 and 30 kg/m2
Exclusion
- Abnormal vital signs (blood pressure and pulse) after 10 minutes supine rest, as judged by the investigator
- Prolonged QTcF \>450 msec or shortened QTcF \<350 msec or family history of long QT syndrome
- Suspicion of known Gilbert's disease
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01225939
Start Date
November 1 2010
End Date
December 1 2010
Last Update
March 2 2011
Active Locations (1)
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1
Research Site
London Bridge, United Kingdom