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

This study has been terminated.
(Study terminated due to treatment-emergent serious adverse events)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00870441
First received: March 25, 2009
Last updated: February 27, 2013
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Safety of ASP2151
Drug: ASP2151
Drug: Valacyclovir
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of ECG, vital signs and physical examination [ Time Frame: Days 1,4,7,10,14,17,21,24 and 28 ] [ Designated as safety issue: No ]

Enrollment: 442
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. ASP2151 Drug: ASP2151
Oral
Active Comparator: 2. Valacyclovir Drug: Valacyclovir
Oral
Other Name: Valtrex
Placebo Comparator: 3. Placebo Drug: Placebo
Oral

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870441

Locations
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
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00870441     History of Changes
Other Study ID Numbers: 15L-CL-019
Study First Received: March 25, 2009
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ASP2151
Valacyclovir
Healthy Volunteers

Additional relevant MeSH terms:
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014