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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870441
Recruitment Status : Terminated (Study terminated due to treatment-emergent serious adverse events)
First Posted : March 27, 2009
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Safety of ASP2151 Drug: ASP2151 Drug: Valacyclovir Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: 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
Study Start Date : March 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1. ASP2151 Drug: ASP2151
Active Comparator: 2. Valacyclovir Drug: Valacyclovir
Other Name: Valtrex
Placebo Comparator: 3. Placebo Drug: Placebo

Primary Outcome Measures :
  1. Assessment of clinical laboratory evaluations and adverse events [ Time Frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit ]

Secondary Outcome Measures :
  1. Assessment of ECG, vital signs and physical examination [ Time Frame: Days 1,4,7,10,14,17,21,24 and 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870441

United States, Florida
Daytona Beach, Florida, United States, 32117
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Indiana
Evansville, Indiana, United States, 47710
United States, Texas
Austin, Texas, United States, 78752
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Global Development

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00870441     History of Changes
Other Study ID Numbers: 15L-CL-019
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: June 2010

Keywords provided by Astellas Pharma Inc:
Healthy Volunteers

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents