Safety of ASP2151
Conditions
Keywords
ASP2151, Valacyclovir, Healthy Volunteers
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.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of clinical laboratory evaluations and adverse events | Days 1,4,7,10,14,17,21,24, 28 and follow-up visit |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of ECG, vital signs and physical examination | Days 1,4,7,10,14,17,21,24 and 28 |
Countries
United States
Outcome results
None listed