Healthy SubjectsPhase 1NCT02222324
A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
A Phase 1 study testing E2609 and Moxifloxacin in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial summary
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. 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?
- E2609 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2014
- 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
- Subjects must meet all of the following criteria to be included in this study:
- Healthy, non-smoking, male or female subjects ages greater than or equal to 18 years to less than or equal to 55 years old at the time of informed consent
- Body mass index (BMI) of greater than or equal to 18 to less than or equal to 30 kg/m2 at Screening
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative betahuman chorionic gonadotropin [B-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], or have a vasectomized partner with confirmed azoospermia, but not oral contraceptive or contraceptive implant) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Hormonal contraceptives (oral or implant) are not permitted forms of contraception in this study. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism)
- Any history of gastrointestinal surgery that may affect PK profiles of study drugs (eg, hepatectomy, nephrectomy, or digestive organ resection)
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline Periods
- History of any medical condition which, in the opinion of the investigator, may interfere with study procedures or compromise subject safety
Show all 28Show fewer
- A prolonged QT/corrected QT interval (QTc) interval (QTc greater than 450 msec) as demonstrated by the mean of triplicate ECGs at Screening or Baseline Periods
- History of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval
- Persistent systolic blood pressure (BP) greater than 130 mmHg or less than 90 mmHg and diastolic BP greater than 85 mmHg or less than 60 mmHg at Screening or Baseline Periods
- Heart rate less than 50 or greater than 100 beats/minute at Screening or Baseline Periods
- History of prolonged QT/QTc interval
- Left bundle branch block at Screening or Baseline Periods
- History of myocardial infarction or active ischemic heart disease
- History of clinically significant arrhythmia or uncontrolled arrhythmia
- Any other clinically significant ECG abnormalities at Screening or Baseline Periods
- Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline Periods
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or who have a positive urine drug or alcohol test at Screening or Baseline Periods
- Use of recreational drugs
- Intake of caffeinated beverages or food within 72 hours before dosing
- Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard], and charbroiled meats) within 1 week before dosing
- Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing
- Use of prescription drugs within 4 weeks before dosing
- Intake of over-the-counter (OTC) medications within 2 weeks before dosing
- Smoking or use of tobacco or nicotine-containing products within 4 weeks before dosing
- Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters)
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, 4-Treatment Crossover Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
Read the detailed description
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day). Eligibility will be determined during the Screening Period. The Randomization Phase will consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period. Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the first day of each treatment period, subjects will receive a single dose of the assigned study drug. During each treatment period, subjects will be required to stay in the clinical unit from the baseline period to 24 hours postdose. Subjects will then be released from the clinic and will undergo a washout interval of at least 13 days, during which time they will return for additional PK sampling.
- Conditions
- Healthy Subjects
- Being tested
- Placebo, E2609, Moxifloxacin
- Keywords
- QTc Interval, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
8 placebo tablets matching E2609
E2609Drug
E2609 will be administered as 8 tablets
MoxifloxacinDrug
Administered as 1 tablet with 7 tablets of placebo matching E2609
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Placebo Receives: Drug: Placebo |
| Treatment B | Experimental | E2609 Low dose Receives: Drug: E2609 |
| Treatment C | Experimental | E2609 High dose Receives: Drug: E2609 |
| Treatment D | Active comparator | Moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings
Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
Measured: Up to 24 hours postdose during each treatment period
Secondary outcomes (13)
Change from baseline in ECG recordings: PR interval
Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Measured: Predose and then up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: QRS interval
Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Measured: Predose and then up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: HR
Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Measured: Predose and then up 24 hours postdose in each treatment period
Change from baseline in ECG recordings: RR interval
Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Measured: Predose and then at up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: T wave morphology
Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Measured: Predose and then at up to 24 hours postdose in each treatment period
Pharmacokinetics of E2609: Cmax
Maximum drug concentration
Measured: Up to 84 Days
Pharmacokinetics of E2609: tmax
Ttime to reach maximum (peak) concentration following drug administration
Measured: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-t)
Area under the concentration x time curve from time = 0 to time of last measurable concentration
Measured: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-72h)
Area under the concentration x time curve from time = 0 to 72 hours postdose
Measured: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-inf)
Area under the concentration x time curve from time = 0 to infinity
Measured: Up to 84 Days
Pharmacokinetics of E2609: t1/2
Terminal elimination half-life
Measured: Up to 84 Days
Pharmacokinetics of E2609: CL/F
Apparent total clearance following extravascular administration
Measured: Up to 84 Days
Pharmacokinetics of E2609: Vz/F
Apparent volume of distribution following extravascular administration
Measured: Up to 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionDec 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222324
- Sponsor's protocol ID
- E2609-A001-004
- Status last verified
- Nov 2015
- First submitted
- 19 Aug 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, 4-Treatment Crossover Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02222324
- Acronym / sponsor ID
- E2609-A001-004
- Conditions
- Healthy Subjects
- Keywords
- QTc Interval, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 2014 (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 thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
Detailed description
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day). Eligibility will be determined during the Screening Period. The Randomization Phase will consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period. Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the first day of each treatment period, subjects will receive a single dose of the assigned study drug. During each treatment period, subjects will be required to stay in the clinical unit from the baseline period to 24 hours postdose. Subjects will then be released from the clinic and will undergo a washout interval of at least 13 days, during which time they will return for additional PK sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: PlaceboPlacebo |
| Treatment B | Experimental | Drug: E2609E2609 Low dose |
| Treatment C | Experimental | Drug: E2609E2609 High dose |
| Treatment D | Active comparator | Drug: MoxifloxacinMoxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, non-smoking, male or female subjects ages greater than or equal to 18 years to less than or equal to 55 years old at the time of informed consent
- Body mass index (BMI) of greater than or equal to 18 to less than or equal to 30 kg/m2 at Screening
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative betahuman chorionic gonadotropin [B-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], or have a vasectomized partner with confirmed azoospermia, but not oral contraceptive or contraceptive implant) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Hormonal contraceptives (oral or implant) are not permitted forms of contraception in this study. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Key exclusion criteria (28 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism)
- Any history of gastrointestinal surgery that may affect PK profiles of study drugs (eg, hepatectomy, nephrectomy, or digestive organ resection)
- Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline Periods
- History of any medical condition which, in the opinion of the investigator, may interfere with study procedures or compromise subject safety
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 |
|---|---|---|
| Placebo8 placebo tablets matching E2609 | Drug | Treatment A |
| E2609E2609 will be administered as 8 tablets | Drug | Treatment B, Treatment C |
| MoxifloxacinAdministered as 1 tablet with 7 tablets of placebo matching E2609 | Drug | Treatment D |
Primary outcome
Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings
Time frame: Up to 24 hours postdose during each treatment period
Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
13 secondary outcomes
Change from baseline in ECG recordings: PR interval
Time frame: Predose and then up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: QRS interval
Time frame: Predose and then up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: HR
Time frame: Predose and then up 24 hours postdose in each treatment period
Change from baseline in ECG recordings: RR interval
Time frame: Predose and then at up to 24 hours postdose in each treatment period
Change from baseline in ECG recordings: T wave morphology
Time frame: Predose and then at up to 24 hours postdose in each treatment period
Pharmacokinetics of E2609: Cmax
Time frame: Up to 84 Days
Pharmacokinetics of E2609: tmax
Time frame: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-t)
Time frame: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-72h)
Time frame: Up to 84 Days
Pharmacokinetics of E2609: AUC(0-inf)
Time frame: Up to 84 Days
Pharmacokinetics of E2609: t1/2
Time frame: Up to 84 Days
Pharmacokinetics of E2609: CL/F
Time frame: Up to 84 Days
Pharmacokinetics of E2609: Vz/F
Time frame: Up to 84 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 3 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 E2609 and Moxifloxacin in people with Healthy Subjects, 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 6 inclusion and 28 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 3 Nov 2015. 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. 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 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 from baseline in QTcF obtained from ECGs extracted from the Holter recordings (time frame: Up to 24 hours postdose during each treatment period). 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 3 Nov 2015.