Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
This study has been terminated.
(Study terminated due to treatment-emergent serious adverse events)
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00870441
First received: March 25, 2009
Last updated: February 27, 2013
Last verified: June 2010
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Purpose
The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Safety of ASP2151 |
Drug: ASP2151 Drug: Valacyclovir Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Assessment of clinical laboratory evaluations and adverse events [ Time Frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assessment of ECG, vital signs and physical examination [ Time Frame: Days 1,4,7,10,14,17,21,24 and 28 ] [ Designated as safety issue: No ]
| Enrollment: | 442 |
| Study Start Date: | March 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. ASP2151 |
Drug: ASP2151
Oral
|
| Active Comparator: 2. Valacyclovir |
Drug: Valacyclovir
Oral
Other Name: Valtrex
|
| Placebo Comparator: 3. Placebo |
Drug: Placebo
Oral
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870441
Locations
| United States, Florida | |
| Daytona Beach, Florida, United States, 32117 | |
| United States, Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47710 | |
| United States, Texas | |
| Austin, Texas, United States, 78752 | |
| Dallas, Texas, United States, 75247 | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Use Central Contact | Astellas Pharma Global Development |
More Information
Additional Information:
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00870441 History of Changes |
| Other Study ID Numbers: | 15L-CL-019 |
| Study First Received: | March 25, 2009 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
ASP2151 Valacyclovir Healthy Volunteers |
Additional relevant MeSH terms:
|
Valacyclovir Acyclovir Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013