Idiopathic Thrombocytopenic Purpura (ITP)Phase 1NCT01437384
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.
A Phase 1 study testing E5501 in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Eisai Inc. at 1 site in United States.
Trial summary
36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. 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 (ITP)
- What is being tested?
- E5501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 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 greater than or equal to 18kg/m2 and less than or equal to 32kg/m2 at the time of Screening and at each Baseline
- Platelet count between 120x109/L and 300x109/L at Baseline
- Women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the treatment phase of the study
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 the study
- 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 thromboses (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 (women, 7.1 mmol/L; men, 8.1 mmol/L) In addition, other standard criteria for healthy volunteers will be used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects
36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.
- Being tested
- E5501
- 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.
E5501Drug
20 mg oral dose of E5501; 240 mg once daily oral dose of sustained release verapamil; 400 mg oral dose of cyclosporine
| Study group | Role | What they receive |
|---|---|---|
| E5501 plus minus verapamil; plus minus cyclosporine | Experimental | Not described Receives: Drug: E5501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of E5501
Measured: Periodically over the course of Days 1-11
Secondary outcomes (1)
Platelet counts
Measured: Periodically over the course of Days 1-34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic Purpura (ITP)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Pastino, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437384
- Sponsor's protocol ID
- E5501-A001-008
- Status last verified
- May 2012
- First submitted
- 19 Sep 2011
- Last updated
- 21 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01437384
- Acronym / sponsor ID
- E5501-A001-008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- First posted
- 20 Sep 2011 (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.
36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E5501 plus minus verapamil; plus minus cyclosporine | Experimental | Drug: E5501 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult men and women (age 18 to 55 years)
- Body mass index greater than or equal to 18kg/m2 and less than or equal to 32kg/m2 at the time of Screening and at each Baseline
- Platelet count between 120x109/L and 300x109/L at Baseline
- Women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the treatment phase of the study
Key exclusion criteria (5 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 the study
- 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 thromboses (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 (women, 7.1 mmol/L; men, 8.1 mmol/L) In addition, other standard criteria for healthy volunteers will be used.
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 |
|---|---|---|
| E550120 mg oral dose of E5501; 240 mg once daily oral dose of sustained release verapamil; 400 mg oral dose of cyclosporine | Drug | E5501 plus minus verapamil; plus minus cyclosporine |
Primary outcome
Plasma concentrations of E5501
Time frame: Periodically over the course of Days 1-11
1 secondary outcome
Platelet counts
Time frame: Periodically over the course of Days 1-34
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 21 May 2012.
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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.
Gina Pastino 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 E5501 in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Eisai Inc. at 1 site 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 4 inclusion and 5 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 21 May 2012. 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 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. 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?
Plasma concentrations of E5501 (time frame: Periodically over the course of Days 1-11). 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 21 May 2012.