Study Comparing the Safety of ASP2151 to Valacyclovir and... | NCT00870441

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

NCT00870441

Sponsor

Astellas Pharma Inc

Status

Terminated

Last Update Posted

Feb 28, 2013Estimated

Enrollment

442Actual

Phase

Phase 1

Conditions

Safety of ASP2151

Interventions

ASP2151
Valacyclovir
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to treatment-emergent serious adverse events

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Mar 25, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2013

Last Update Posted Date

Feb 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

442Actual

Label	Type	Intervention Names
1. ASP2151	Experimental	Drug: ASP2151
2. Valacyclovir	Active Comparator	Drug: Valacyclovir
3. Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ASP2151	Drug	Oral	1. ASP2151
Valacyclovir

Measure	Description	Time Frame
Assessment of clinical laboratory evaluations and adverse events		Days 1,4,7,10,14,17,21,24, 28 and follow-up visit

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Daytona Beach	Florida	32117	United States

ID	Term
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687