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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Safety of ASP2151

In brief

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

Key facts

Study ID

NCT00870441

Run by

Astellas Pharma Inc

People needed

442

Starts

2009-03-01

Expected to finish

2010-04-01

Last updated by the study team

2013-02-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Daytona Beach, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Evansville, Indiana, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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