Healthy SubjectsPhase 1NCT01261156
A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects
A Phase 1 study testing E5555 100 mg and diltiazem and E5555 300 mg and diltiazem in people with Healthy Subjects, run by Eisai Inc. at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E5555 100 mg and diltiazem and E5555 300 mg and diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide written informed consent
- Healthy, non-smoking, male or female subjects aged greater than or equal to 18 years to 55 years
- Body mass index (BMI) greater than or equal to 18 and less than or equal to 32 kg/m2 at Screening
- All females must have a negative serum beta human chorionic gonadotropin test result at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception commencing at least one menstrual cycle prior to starting study drug, throughout the entire study period and for 90 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women or subjects who have been surgically sterilized or who are otherwise proven sterile.
- Male subjects who are partners of women of childbearing potential and are not abstinent or have not undergone a successful vasectomy must use, or their partners must use, a highly effective method of contraception commencing at least one menstrual cycle prior to starting study drug, throughout the entire study period and for 90 days after study drug discontinuation.
- Are willing and able to comply with all aspects of the protocol.
Who cannot join
- A family history, past medical history or clinical signs or symptoms of a bleeding diathesis
- History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis etc
- Subjects with a history of spontaneous gum bleeding or clinical signs or symptoms on physical exam
- Clinically significant ocular disease or untreated visual or ocular symptoms
- Clinically significant abnormal electrocardiograms ECGs prior to dosing (Screening or Baselines) including a QT interval corrected for heart rate using Fredericia's formula (QTcF) and/or Bazett's formula (QTcB) greater than 450 ms
- Any history or past medical condition that will result in QTc prolongation or tachyarrhythmia such as Torsades de Points (includes hypokalemia, known family history of long QT syndrome, or any other known risk factors for Torsades de Points)
Show all 12Show fewer
- A platelet count less than 150,000 or greater than 390,000 per mL at Screening or Baseline Period 1
- Abnormal (less than 80%) arachidonic acid induced platelet aggregation at Baseline Period 1
- History of unexplained syncope, hepato-bliary disease, sinus bradycardia, heart blocks, sick-sinus syndrome, cardiogenic shock, heart failure, seizures, or chronic obstructive lung disease
- Subjects with hypotension (less than 90 mm Hg systolic) and bradycardia (HR less than 40 beats per minute) or symptomatic bradycardia (HR less than 50 beats per minute)
- Received blood, donated blood, or experienced significant blood loss within 60 days prior to check-in
- Hypersensitivity to diltiazem or related compounds or ingredients in the formulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-Sequence Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects
The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.
Read the detailed description
This is an open-label, 2-arm study to evaluate the effects of diltiazem given in conjunction with E5555 on the PK of diltiazem and its metabolites. This is a Phase 1 study of 24 healthy male and female subjects that will be conducted at a single site. The planned duration of treatment for each subject is approximately 15 days including 1 day in Treatment Period 1 and 14 days in Treatment Period 2.
- Conditions
- Healthy Subjects
- Being tested
- E5555 100 mg and diltiazem, E5555 300 mg and diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E5555 100 mg and diltiazemDrug
E5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
E5555 300 mg and diltiazemDrug
E5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1 | Experimental | Not described Receives: Drug: E5555 100 mg and diltiazem |
| Study Arm 2 | Experimental | Not described Receives: Drug: E5555 300 mg and diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites.
Measured: 18 days
Evaluate the effects of diltiazem on the thrombin- and thrombin receptor activating peptide (TRAP) -induced platelet aggregation of E5555 and its known metabolites
Measured: 18 days
Secondary outcomes (3)
To evaluate the effects of co-adminstration of diltiazem and E5555 on the PK(ie. Cmax, Tmax, AUC and half-life) of diltiazem and its metabolites
Measured: 18 days
To evaluate effects of co-adminstration of diltiazem and E5555 on QTcF compared to E5555 alone
Measured: 18 days
To assess safety and tolerability of a single dose of E5555 when given alone or in combination with diltiazem by recording the number of all adverse events following drug administration
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chukwuemeka Okereke, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261156
- Sponsor's protocol ID
- E5555-A001-022
- Status last verified
- Jul 2014
- First submitted
- 16 Nov 2010
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Sequence Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01261156
- Acronym / sponsor ID
- E5555-A001-022
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 16 Dec 2010 (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 purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.
Detailed description
This is an open-label, 2-arm study to evaluate the effects of diltiazem given in conjunction with E5555 on the PK of diltiazem and its metabolites. This is a Phase 1 study of 24 healthy male and female subjects that will be conducted at a single site. The planned duration of treatment for each subject is approximately 15 days including 1 day in Treatment Period 1 and 14 days in Treatment Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 | Experimental | Drug: E5555 100 mg and diltiazem |
| Study Arm 2 | Experimental | Drug: E5555 300 mg and diltiazem |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provide written informed consent
- Healthy, non-smoking, male or female subjects aged greater than or equal to 18 years to 55 years
- Body mass index (BMI) greater than or equal to 18 and less than or equal to 32 kg/m2 at Screening
- All females must have a negative serum beta human chorionic gonadotropin test result at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception commencing at least one menstrual cycle prior to starting study drug, throughout the entire study period and for 90 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women or subjects who have been surgically sterilized or who are otherwise proven sterile.
- Male subjects who are partners of women of childbearing potential and are not abstinent or have not undergone a successful vasectomy must use, or their partners must use, a highly effective method of contraception commencing at least one menstrual cycle prior to starting study drug, throughout the entire study period and for 90 days after study drug discontinuation.
Key exclusion criteria (12 listed)
- A family history, past medical history or clinical signs or symptoms of a bleeding diathesis
- History of any medical condition which will result in an increased risk of bleeding including but not limited to active or recurrent gastric ulcers, recent head trauma or surgery, severe hypertension, bacterial endocarditis etc
- Subjects with a history of spontaneous gum bleeding or clinical signs or symptoms on physical exam
- Clinically significant ocular disease or untreated visual or ocular symptoms
- Clinically significant abnormal electrocardiograms ECGs prior to dosing (Screening or Baselines) including a QT interval corrected for heart rate using Fredericia's formula (QTcF) and/or Bazett's formula (QTcB) greater than 450 ms
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 |
|---|---|---|
| E5555 100 mg and diltiazemE5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2. | Drug | Study Arm 1 |
| E5555 300 mg and diltiazemE5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2. | Drug | Study Arm 2 |
Primary outcome
Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites.
Time frame: 18 days
Evaluate the effects of diltiazem on the thrombin- and thrombin receptor activating peptide (TRAP) -induced platelet aggregation of E5555 and its known metabolites
Time frame: 18 days
3 secondary outcomes
To evaluate the effects of co-adminstration of diltiazem and E5555 on the PK(ie. Cmax, Tmax, AUC and half-life) of diltiazem and its metabolites
Time frame: 18 days
To evaluate effects of co-adminstration of diltiazem and E5555 on QTcF compared to E5555 alone
Time frame: 18 days
To assess safety and tolerability of a single dose of E5555 when given alone or in combination with diltiazem by recording the number of all adverse events following drug administration
Time frame: 18 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 11 Jul 2014.
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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.
Chukwuemeka Okereke study director
Eisai Limited
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 E5555 100 mg and diltiazem and E5555 300 mg and diltiazem in people with Healthy Subjects, run by Eisai Inc. at 1 site in Netherlands.
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 6 inclusion and 12 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 11 Jul 2014. 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 Netherlands. 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?
Evaluate the effects of diltiazem on the pharmacokinetics (PK ie. Cmax, Tmax, AUC and half-life) of E5555 and its known metabolites. (time frame: 18 days). The study lists 2 primary outcomes in all. 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 11 Jul 2014.