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

Phase 1

Terminated

• Conditions: Safety of ASP2151
• Interventions: Drug: ASP2151; Drug: Valacyclovir; Drug: Placebo

• Registration Number: NCT00870441
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 442

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. ASP2151	ASP2151	-
2. Valacyclovir	Valacyclovir	-
3. Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Assessment of clinical laboratory evaluations and adverse events	Days 1,4,7,10,14,17,21,24, 28 and follow-up visit

Secondary Outcome Measures

Name	Time	Method
Assessment of ECG, vital signs and physical examination	Days 1,4,7,10,14,17,21,24 and 28