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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2010

Interventions

  • Drug: ASP2151
    • Oral
  • Drug: Valacyclovir
    • Oral
  • Drug: Placebo
    • Oral

Arms, Groups and Cohorts

  • Experimental: 1. ASP2151
  • Active Comparator: 2. Valacyclovir
  • Placebo Comparator: 3. Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Use Central Contact, Study Director, Astellas Pharma Global Development

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