Clinical trial NCT00870441: Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Safety of ASP2151
Keywords: ASP2151
Valacyclovir
Healthy Volunteers
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Assessment of clinical laboratory evaluations and adverse events
timeFrame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit
Secondary outcomes:
measure: Assessment of ECG, vital signs and physical examination
timeFrame: Days 1,4,7,10,14,17,21,24 and 28
Other outcomes:
Locations:
city: Daytona Beach
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Evansville
country: United States
state: Indiana
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References: