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

A Phase 1, Randomized, Double-Blind, Multiple Dose, Multi-Center Study to Compare the Safety of ASP2151 to Valacylcovir and Placebo in Healthy Male and Female Subjects

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

Study Overview

• Status: Terminated
• Conditions: Safety of ASP2151
• Intervention / Treatment: Drug: Placebo; Drug: ASP2151; Drug: Valacyclovir

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
  • Indiana
    • Evansville, Indiana, United States, 47710
  • Texas
    • Austin, Texas, United States, 78752
    • Dallas, Texas, United States, 75247

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. ASP2151	Drug: ASP2151; Oral
Active Comparator: 2. Valacyclovir	Drug: Valacyclovir; Oral; Other Names: Valtrex
Placebo Comparator: 3. Placebo	Drug: Placebo; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on JAPIC

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 25, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (Estimate): March 27, 2009

Study Record Updates

• Last Update Posted (Estimate): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Valacyclovir; ASP2151
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Valacyclovir
• Other Study ID Numbers: 15L-CL-019