Healthy SubjectsPhase 1NCT02947711

Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects

A Phase 1 study testing E2027 and Diltiazem ER in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Phase 1, open-label, single-sequence, drug-drug Interaction study is conducted to evaluate the effect of diltiazem extended release (ER) (a moderate CYP3A inhibitor and P glycoprotein [Pgp] inhibitor) on the pharmacokinetics (PK) of a single oral dose of E2027 in healthy participants. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: E2027 and Diltiazem ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Oct 2016to Jan 2017
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoking, male or female participants, ≥18 years old and ≤50 years old at the time of informed consent
Body mass index of 18 to 32 kilograms per meters squared (kg/m^2) at Screening

Who cannot join

Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks prior to the first dose
Females who are: (a) breastfeeding; or (b) pregnant at Screening or Baseline (documented by a negative beta human chorionic gonadotropin [β-hCG] (or human chorionic gonadotropin [hCG]) test with a sensitivity of at least 25 International Units per Liter (IU/L) or equivalent units of β-hCG [or hCG]). Note: A negative urine pregnancy test is required before the administration of the first dose.
Females of childbearing potential who:
Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double barrier method [such as condom plus diaphragm with spermicide] or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation. Note: Hormonal contraceptives are not allowed.
Are currently (for at least 30 days) abstinent, and do not agree to use a double barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation NOTE: 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 (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month prior to first dose).
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.

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Evidence of disease that may influence the outcome of the study within 4 weeks prior to the first dose (e.g., psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism)
Any history of abdominal surgery that may affect pharmacokinetic profiles of E2027 (e.g., hepatectomy, nephrectomy, digestive organ resection). Participants with a history cholecystectomy or appendectomy are not excluded.
Any other clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram (ECG) finding (including a PR greater than 210 milliseconds (msec), a QRS greater than 110 msec), or laboratory test results that requires medical treatment at Screening or Baseline as determined by the Principal Investigator or designee
A prolonged QT/QTc interval (QTc greater than 450 msec) demonstrated on ECG at Screening or Baseline (based on average of triplicate ECGs). A history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
Left bundle branch block at Screening or Baseline
Persistent systolic blood pressure (BP) greater than 160 or less than 100 millimeters of mercury (mmHg) or diastolic BP greater than 100 or less than 50 mmHg at Screening or Baseline
Persistent pulse rate less than 50 beats/minute (min) or more than 90 beats/min at Screening or Baseline
History of myocardial infarction, ischemic heart disease, or cardiac failure at Screening
History of clinically significant arrhythmia or uncontrolled arrhythmia
Known history of clinically significant drug allergy at Screening or Baseline
Participants with any contraindications to diltiazem Extended Release
Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
Known to be human immunodeficiency virus (HIV) positive at Screening
Active viral hepatitis (A, 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 those who have a positive urine drug or alcohol test at Screening or Baseline
Participants who smoke or have used tobacco or nicotine-containing products within 4 weeks prior to first dose
A Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation score of 4 or 5 at Screening or Baseline, or for the period within 6 months before Screening or Baseline, or any lifetime suicidal behavior
Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
Engagement in strenuous exercise within 2 weeks prior to first dose (e.g., marathon runners, weight lifters)
Intake of caffeinated beverages or caffeinated food within 72 hours prior to first dose
Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard], and charbroiled meats) within 1 week prior to first dose
Intake of herbal preparations containing St. John's Wort within 4 weeks prior to first dose
Intake of over-the-counter (OTC) medications within 14 days (or 5 half-lives, whichever is longer) before dosing unless the Principal Investigator and sponsor medical monitor consider that they do not compromise participant safety or study assessments
Use of any prescription drugs within 4 weeks prior to first dose

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
San Antonio, Texas

Other trials in United States

About this study

Official title: An Open-label, Single-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects

Conditions: Healthy Subjects
Being tested: E2027, Diltiazem ER
Keywords: E2027, Healthy participants, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E2027Drug
2 x 50 mg capsules, once daily on Day 1 and Day 12
Diltiazem ERDrug
1 x 300 mg capsule, once daily on Days 7 through 24

Study groups in NCT02947711
Study group	Role	What they receive
E2027 100 mg alone and in combination with diltiazem ER 300 mg	Experimental	E2027 100 milligrams (mg) will be administered orally on Days 1 and 12. Diltiazem extended release (ER) 300 mg will be administered alone on Days 7 to 24; however, on the morning of Day 12 it will be coadministered with E2027 100 mg. Receives: Drug: E2027; Drug: Diltiazem ER

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with any adverse event (AE) and any serious adverse event (SAE)
Measured: up to Day 27
Mean values for the indicated hematology and blood chemistry parameters at the indicated time points
Measured: Screening; Baseline; Day 6; Day 11; Follow-up/Early Termination (FU/ET) (Day 27); Unscheduled Visits
Mean urine values at the indicated time points
Measured: Screening; Baseline; Day 6; Day 11; FU/ET (Day 27); Unscheduled Visits
Mean values for the indicated vital signs at the indicated time points
Day 1: predose; 2, 4, 6, 8, and 12 hours postdose. Day 2: 24 hours postdose. Day 12: predose; 2, 4, 6, 8, and 12 hours postdose; Day 13: 24 hours postdose)
Measured: Screening; Baseline; Days 1-6; Days 12-25; FU/ET (Day 27); Unscheduled Visits
Mean values for the indicated electrocardiogram (ECG) parameters at the indicated time points
Day 1: predose; 2, 4, 6, 8, and 12 hours postdose. Day 2: 24 hours postdose. Day 12: predose; 2, 4, 6, 8, and 12 hours postdose. Day 13: 24 hours postdose
Measured: Screening; Baseline; Days 1-6; Days 12-25; FU/ET (Day 27); Unscheduled Visits
Mean values for the indicted physical examination parameters at the indicated time points
Measured: Screening; Baseline; Day 11; Day 25; FU/ET (Day 27); Unscheduled Visits
Mean maximum drug concentration (Cmax) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean area under the concentration x time curve from time zero to time 144 hours measurable concentration postdose (AUC[0-144]) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean area under the concentration x time curve from time zero to time infinity postdose (AUC[0-inf]) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose

Secondary outcomes (5)

Mean area under the concentration x time curve from time zero to time 72 hours measurable concentration postdose (AUC[0-72]) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean time to reach maximum (peak) concentration (tmax) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean terminal elimination half-life (t1/2) for E2027 and metabolites at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean apparent total body clearance after oral administration (CL/F) for E2027 at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean apparent volume of distribution in the terminal phase (Vz/F) for E2027 at Day 1 and Day 12
Measured: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Jan 2017

First posted28 Oct 2016 (estimated)
Study startOct 2016
Primary completionNov 2016
Study completionJan 2017

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02947711
Sponsor's protocol ID: E2027-A001-003
Status last verified: Feb 2017
First submitted: 26 Oct 2016
Last updated: 7 Mar 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects
ClinicalTrials.gov ID: NCT02947711
Acronym / sponsor ID: E2027-A001-003
Conditions: Healthy Subjects
Keywords: E2027, Healthy participants, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 28 Oct 2016 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
E2027 100 mg alone and in combination with diltiazem ER 300 mg	Experimental	Drug: E2027, Drug: Diltiazem ERE2027 100 milligrams (mg) will be administered orally on Days 1 and 12. Diltiazem extended release (ER) 300 mg will be administered alone on Days 7 to 24; however, on the morning of Day 12 it will be coadministered with E2027 100 mg.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Non-smoking, male or female participants, ≥18 years old and ≤50 years old at the time of informed consent
Body mass index of 18 to 32 kilograms per meters squared (kg/m^2) at Screening

Key exclusion criteria (30 listed)

Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks prior to the first dose
Females who are: (a) breastfeeding; or (b) pregnant at Screening or Baseline (documented by a negative beta human chorionic gonadotropin [β-hCG] (or human chorionic gonadotropin [hCG]) test with a sensitivity of at least 25 International Units per Liter (IU/L) or equivalent units of β-hCG [or hCG]). Note: A negative urine pregnancy test is required before the administration of the first dose.
Females of childbearing potential who:
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
Evidence of disease that may influence the outcome of the study within 4 weeks prior to the first dose (e.g., psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism)

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
E20272 x 50 mg capsules, once daily on Day 1 and Day 12	Drug	E2027 100 mg alone and in combination with diltiazem ER 300 mg
Diltiazem ER1 x 300 mg capsule, once daily on Days 7 through 24	Drug	E2027 100 mg alone and in combination with diltiazem ER 300 mg

Primary outcome

Number of participants with any adverse event (AE) and any serious adverse event (SAE)
Time frame: up to Day 27
Mean values for the indicated hematology and blood chemistry parameters at the indicated time points
Time frame: Screening; Baseline; Day 6; Day 11; Follow-up/Early Termination (FU/ET) (Day 27); Unscheduled Visits
Mean urine values at the indicated time points
Time frame: Screening; Baseline; Day 6; Day 11; FU/ET (Day 27); Unscheduled Visits
Mean values for the indicated vital signs at the indicated time points
Time frame: Screening; Baseline; Days 1-6; Days 12-25; FU/ET (Day 27); Unscheduled Visits
Day 1: predose; 2, 4, 6, 8, and 12 hours postdose. Day 2: 24 hours postdose. Day 12: predose; 2, 4, 6, 8, and 12 hours postdose; Day 13: 24 hours postdose)
Mean values for the indicated electrocardiogram (ECG) parameters at the indicated time points
Time frame: Screening; Baseline; Days 1-6; Days 12-25; FU/ET (Day 27); Unscheduled Visits
Day 1: predose; 2, 4, 6, 8, and 12 hours postdose. Day 2: 24 hours postdose. Day 12: predose; 2, 4, 6, 8, and 12 hours postdose. Day 13: 24 hours postdose
Mean values for the indicted physical examination parameters at the indicated time points
Time frame: Screening; Baseline; Day 11; Day 25; FU/ET (Day 27); Unscheduled Visits
Mean maximum drug concentration (Cmax) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean area under the concentration x time curve from time zero to time 144 hours measurable concentration postdose (AUC[0-144]) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean area under the concentration x time curve from time zero to time infinity postdose (AUC[0-inf]) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose

5 secondary outcomes

Mean area under the concentration x time curve from time zero to time 72 hours measurable concentration postdose (AUC[0-72]) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean time to reach maximum (peak) concentration (tmax) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean terminal elimination half-life (t1/2) for E2027 and metabolites at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean apparent total body clearance after oral administration (CL/F) for E2027 at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose
Mean apparent volume of distribution in the terminal phase (Vz/F) for E2027 at Day 1 and Day 12
Time frame: Days 1 and 12: predose; 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 18 hours postdose

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 7 Mar 2017.
Individual participant dataSharing planned: Yes

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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 E2027 and Diltiazem ER in people with Healthy Subjects, run by Eisai Co., Ltd. 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 2 inclusion and 30 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 7 Mar 2017. 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?

Number of participants with any adverse event (AE) and any serious adverse event (SAE) (time frame: up to Day 27). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02947711.

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 7 Mar 2017.