Status:
TERMINATED
Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Safety of ASP2151
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.
Eligibility Criteria
Inclusion
- Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-35 kg/m2, inclusive
- If female, subject is using a medically acceptable contraceptive method along with a double-barrier method to prevent pregnancy and agrees to continue using this method throughout study; and is not lactating or pregnant as documented by a negative serum pregnancy test
- The subject is medically healthy, with a normal 12-lead electrocardiogram (ECG)
Exclusion
- History of any clinically significant disease or malignancy excluding non-melanoma skin cancer
- History of liver disease, liver dysfunction, liver enzyme elevations, or Gilbert's disease
- History of acute or chronic pancreatitis or pancreatic insufficiency
- History of gout, hyperuricemia, or crystalluria
- History of chronic pain requiring medical therapy
- Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
- Positive test for human immunodeficiency virus (HIV) antibody
- Clinical laboratory tests outside the normal limits and considered by the investigator to be clinically significant
- The subject has difficulty swallowing tablets
- Clinically significant illness within one month prior to study drug administration
- History of drug or alcohol abuse within 2 years prior to study drug administration
- Treatment with prescription medication (with the exception of contraceptives and hormone replacement therapy (HRT)) or complementary and alternative medicines (CAM) within 14 days; over-the-counter products with exception of ibuprofen within 14 days; or alcohol, grapefruit or grapefruit juice containing beverage within 72 hours
- Donated blood or has had significant blood loss within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00870441
Start Date
March 1 2009
End Date
April 1 2010
Last Update
February 28 2013
Active Locations (5)
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1
Daytona Beach, Florida, United States, 32117
2
Honolulu, Hawaii, United States, 96813
3
Evansville, Indiana, United States, 47710
4
Austin, Texas, United States, 78752