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

NCT00870441 | Terminated Phase 1

• 1 other identifier: 15L-CL-019
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 5

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.

Conditions

Safety of ASP2151

Keywords

ASP2151; Valacyclovir; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Assessment of clinical laboratory evaluations and adverse events

  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

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

Study Arms (3)

1. ASP2151

EXPERIMENTAL

Drug: ASP2151

2. Valacyclovir

ACTIVE COMPARATOR

Drug: Valacyclovir

3. Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ASP2151 DRUG

Oral

1. ASP2151

Valacyclovir DRUG

Oral

Also known as: Valtrex

2. Valacyclovir

Placebo DRUG

Oral

3. Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Unknown Facility

Daytona Beach, Florida, 32117, United States

Location

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

Unknown Facility

Evansville, Indiana, 47710, United States

Location

Unknown Facility

Austin, Texas, 78752, United States

Location

Unknown Facility

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

ASP2151; Valacyclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 28, 2013

Record last verified: 2010-06

Locations

US (5)