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

Astellas

Status and phase: Terminated; Phase 1

Conditions: Safety of ASP2151

Treatments: Drug: Placebo; Drug: ASP2151; Drug: Valacyclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870441

15L-CL-019

Details and patient eligibility

About

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

Enrollment: 442 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

442 participants in 3 patient groups, including a placebo group

1. ASP2151

Experimental group

Treatment:

Drug: ASP2151

2. Valacyclovir

Active Comparator group

Treatment:

Drug: Valacyclovir

3. Placebo

Placebo Comparator group

Treatment:

Drug: Placebo