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

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

Official Title
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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

Conditions
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Safety of ASP2151

Intervention / Treatment
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* Drug: ASP2151
* Drug: Valacyclovir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. ASP2151<br> | Drug: ASP2151<br>* Oral<br>|
| Active Comparator: 2. Valacyclovir<br> | Drug: Valacyclovir<br>* Oral<br>* Other names: Valtrex;|
| Placebo Comparator: 3. Placebo<br> | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP2151, Valacyclovir, Healthy Volunteers