Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
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| ClinicalTrials.gov Identifier: NCT00870441 |
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Recruitment Status :
Terminated
(Study terminated due to treatment-emergent serious adverse events)
First Posted : March 27, 2009
Last Update Posted : February 28, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Safety of ASP2151 | Drug: ASP2151 Drug: Valacyclovir Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | April 2010 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1. ASP2151 |
Drug: ASP2151
Oral |
| Active Comparator: 2. Valacyclovir |
Drug: Valacyclovir
Oral
Other Name: Valtrex |
| Placebo Comparator: 3. Placebo |
Drug: Placebo
Oral |
- Assessment of clinical laboratory evaluations and adverse events [ Time Frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit ]
- Assessment of ECG, vital signs and physical examination [ Time Frame: Days 1,4,7,10,14,17,21,24 and 28 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870441
| 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 | |
| Study Director: | Use Central Contact | Astellas Pharma Global Development |
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00870441 |
| Other Study ID Numbers: |
15L-CL-019 |
| First Posted: | March 27, 2009 Key Record Dates |
| Last Update Posted: | February 28, 2013 |
| Last Verified: | June 2010 |
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ASP2151 Valacyclovir Healthy Volunteers |
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Valacyclovir Antiviral Agents Anti-Infective Agents |

