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

NCT ID: NCT00870441

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

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.

Detailed Description

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Conditions

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Safety of ASP2151

Keywords

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ASP2151 Valacyclovir Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. ASP2151

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral

2. Valacyclovir

Group Type ACTIVE_COMPARATOR

Valacyclovir

Intervention Type DRUG

Oral

3. Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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ASP2151

Oral

Intervention Type DRUG

Valacyclovir

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Other Intervention Names

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Valtrex

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Daytona Beach, Florida, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Evansville, Indiana, United States

Site Status

Austin, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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15L-CL-019

Identifier Type: -

Identifier Source: org_study_id