Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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