CClinicalTrials.gg
TerminatedNCT00870441Updated Feb 28, 2013

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

A Phase 1 interventional study of ASP2151 and Valacyclovir in Safety of ASP2151, sponsored by Astellas Pharma Inc. Terminated at 5 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-28.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Why this study was terminated
Study terminated due to treatment-emergent serious adverse events
Phase
Phase 1
Study type
Interventional
Enrollment
442
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Safety of ASP2151

Keywords

  • ASP2151
  • Valacyclovir
  • Healthy Volunteers
03

In context

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
442 participants (actual)

Study arms

  • Experimental
    1. ASP2151

    Drug: ASP2151

  • Active comparator
    2. Valacyclovir

    Drug: Valacyclovir

  • Placebo comparator
    3. Placebo

    Drug: Placebo

Interventions

  • DrugASP2151

    Oral

  • DrugValacyclovir

    Oral

    Also known as: Valtrex

  • DrugPlacebo

    Oral

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Assessment of ECG, vital signs and physical examination

    Time frame: Days 1,4,7,10,14,17,21,24 and 28

07

Study locations

5 sites
  • Daytona Beach, Florida 32117, United States
  • Honolulu, Hawaii 96813, United States
  • Evansville, Indiana 47710, United States
  • Austin, Texas 78752, United States
  • Dallas, Texas 75247, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00870441
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Mar 27, 2009
Start date
Mar 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Feb 28, 2013

Study contacts

Use Central Contact
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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