Idiopathic Thrombocytopenic PurpuraPhase 1NCT01549054
A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
A Phase 1 study testing 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution and 10-mg dose of E5501-P21% powder in people with Idiopathic Thrombocytopenic Purpura, run by Eisai Inc. at 1 site in United Kingdom.
Trial summary
This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution and 10-mg dose of E5501-P21% powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Aug 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women (age ≥ 18 to ≤ 55 years)
- Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
- Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
- Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.
- In addition, other standard criteria for healthy subjects will be used.
Who cannot join
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
- Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
- Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
- History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
- Hemoglobin less than the lower limit of normal levels.
- In addition, other standard criteria for healthy subjects will be used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects
This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution, 10-mg dose of E5501-P21% powder, 10-mg dose of E5501 lipid-based oral
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-mg dose of E5501 2G tabletDrug
Treatment A: Single 10-mg dose of E5501 2G tablet
10-mg dose of E5501 cyclodextrin oral solutionDrug
Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
10-mg dose of E5501-P21% powderDrug
Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
10-mg dose of E5501 lipid-based oralDrug
Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 10-mg dose of E5501 2G tablet | Experimental | Not described Receives: Drug: 10-mg dose of E5501 2G tablet |
| 10-mg dose of E5501 cyclodextrin oral solution | Experimental | Not described Receives: Drug: 10-mg dose of E5501 cyclodextrin oral solution |
| 10-mg dose of E5501-P21% powder | Experimental | Not described Receives: Drug: 10-mg dose of E5501-P21% powder |
| 10-mg dose of E5501 lipid-based oral | Experimental | Not described Receives: Drug: 10-mg dose of E5501 lipid-based oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
Measured: 133 days
Secondary outcomes (1)
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food
Measured: 133 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhaskar Rege, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549054
- Sponsor's protocol ID
- E5501-G000-012
- Status last verified
- Oct 2013
- First submitted
- 31 Jan 2012
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01549054
- Acronym / sponsor ID
- E5501-G000-012
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Mar 2012 (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.
This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10-mg dose of E5501 2G tablet | Experimental | Drug: 10-mg dose of E5501 2G tablet |
| 10-mg dose of E5501 cyclodextrin oral solution | Experimental | Drug: 10-mg dose of E5501 cyclodextrin oral solution |
| 10-mg dose of E5501-P21% powder | Experimental | Drug: 10-mg dose of E5501-P21% powder |
| 10-mg dose of E5501 lipid-based oral | Experimental | Drug: 10-mg dose of E5501 lipid-based oral |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult men and women (age ≥ 18 to ≤ 55 years)
- Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
- Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
- Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.
- In addition, other standard criteria for healthy subjects will be used.
Key exclusion criteria (6 listed)
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
- Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
- Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
- History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
- Hemoglobin less than the lower limit of normal levels.
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 |
|---|---|---|
| 10-mg dose of E5501 2G tabletTreatment A: Single 10-mg dose of E5501 2G tablet | Drug | 10-mg dose of E5501 2G tablet |
| 10-mg dose of E5501 cyclodextrin oral solutionTreatment B: Single 10-mg dose of E5501 cyclodextrin oral solution | Drug | 10-mg dose of E5501 cyclodextrin oral solution |
| 10-mg dose of E5501-P21% powderTreatment C: Single 10-mg dose of E5501-P21% powder oral suspension | Drug | 10-mg dose of E5501-P21% powder |
| 10-mg dose of E5501 lipid-based oralTreatment D: Single 10-mg dose of E5501 lipid-based oral suspension | Drug | 10-mg dose of E5501 lipid-based oral |
Primary outcome
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
Time frame: 133 days
1 secondary outcome
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food
Time frame: 133 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
Bhaskar Rege study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10-mg dose of E5501 2G tablet, 10-mg dose of E5501 cyclodextrin oral solution and 10-mg dose of E5501-P21% powder in people with Idiopathic Thrombocytopenic Purpura, run by Eisai Inc. at 1 site in United Kingdom.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax (time frame: 133 days). 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 1 Nov 2013.