Safety of ASP2151Phase 1NCT00870441
Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers
A Phase 1 study testing ASP2151 and Valacyclovir in people with Safety of ASP2151, run by Astellas Pharma Inc at 5 sites in United States.
Trial summary
The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety of ASP2151
- What is being tested?
- ASP2151 and Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Austin, Texas, 78752
Study site
Dallas, Texas, 75247
Study site
Daytona Beach, Florida, 32117
Study site
Evansville, Indiana, 47710
Study site
Honolulu, Hawaii, 96813
About this study
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
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
- Being tested
- ASP2151, Valacyclovir, Placebo
- Keywords
- ASP2151, Valacyclovir, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
Oral
ValacyclovirDrug
Also called Valtrex
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1. ASP2151 | Experimental | Not described Receives: Drug: ASP2151 |
| 2. Valacyclovir | Active comparator | Not described Receives: Drug: Valacyclovir |
| 3. Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical laboratory evaluations and adverse events
Measured: 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
Measured: Days 1,4,7,10,14,17,21,24 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Study terminated due to treatment-emergent serious adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of ASP2151Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870441
- Sponsor's protocol ID
- 15L-CL-019
- Status last verified
- Jun 2010
- First submitted
- 25 Mar 2009
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00870441
- Acronym / sponsor ID
- 15L-CL-019
- Conditions
- Safety of ASP2151
- Keywords
- ASP2151, Valacyclovir, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to treatment-emergent serious adverse events
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. ASP2151 | Experimental | Drug: ASP2151 |
| 2. Valacyclovir | Active comparator | Drug: Valacyclovir |
| 3. Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP2151Oral | Drug | 1. ASP2151 |
| ValacyclovirAlso: ValtrexOral | Drug | 2. Valacyclovir |
| PlaceboOral | Drug | 3. Placebo |
Primary outcome
Assessment of clinical laboratory evaluations and adverse events
Time frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit
1 secondary outcome
Assessment of ECG, vital signs and physical examination
Time frame: Days 1,4,7,10,14,17,21,24 and 28
Results and safety
The study was stopped early (reason given: Study terminated due to treatment-emergent serious adverse events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Global Development
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP2151 and Valacyclovir in people with Safety of ASP2151, run by Astellas Pharma Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to treatment-emergent serious adverse events). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical laboratory evaluations and adverse events (time frame: Days 1,4,7,10,14,17,21,24, 28 and follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.