Overview
A Study Conducted Over 3 Periods to Look at the Drug in the Body
Status:
Completed
Completed
Trial end date:
2010-12-01
2010-12-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
A study conducted over 3 periods to look at the drug in the body.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:- 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 Criteria:
- 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