- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683185
A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants
July 14, 2021 updated by: Eisai Co., Ltd.
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Japanese Healthy Adult Subjects
The primary purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple ascending oral doses of E6742 in Japanese healthy adult participants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Bunkyō-Ku, Tokyo, Japan
- Eisai Trial Site #1
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-smoking, male or female Japanese, greater than or equal to (>=) age 20 years and less than or equal to (<=) 55 years old at the time of informed consent
- Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per meter square (kg/m^2) at Screening
Exclusion Criteria:
- Females who are breastfeeding or pregnant at Screening or Baseline
Females of childbearing potential who:
Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- Total abstinence
- An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- A contraceptive implant
- An oral contraceptive
- Have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection within 4 weeks before dosing
- Any history of gastrointestinal surgery that may affect PK profiles of E6742 at Screening
- Any clinically abnormal symptom or organ impairment found by medical history, ophthalmic examination or chest X ray test at Screening, or founded by physical examinations, vital signs, ECG finding, or laboratory test results at Screening or Baseline
- A prolonged QTc corrected using Fridericia's method (QTcF) interval (QTcF greater than [>] 450 millisecond [ms]) demonstrated on ECG at Screening or Baseline. A history of risk factors for torsade de pointes or the use of concomitant medications that prolonged the QT/QTc interval
- Persistent systolic blood pressure >130 millimeter of mercury (mmHg) or diastolic blood pressure >85 mmHg diastolic at Screening or Baseline
- Heart rate less than 45 or more than 100 beats per min at Screening or Baseline
- Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
- Any lifetime history of psychiatric disease
- Any current psychiatric symptoms as indicated by a standard screening tool (Patient Health Questionnaire 9 [PHQ 9])
- Any suicidal ideation with intent with or without a plan within Screening or 6 months before Screening (that is, answering "Yes" to questions 4 or 5 on the C-SSRS)
- History of autoimmune disease or immunodeficiency
- Known to be positive for tuberculosis test (T-spot. TB Test) at Screening
- Received immunoglobulin or blood preparation within 6 months before the study treatment
- Received inoculation within 4 weeks before the study treatment (8 weeks before in case of live or attenuated vaccine)
- Family living together or cohabitant of a patient with an influenza virus infection
- In contact with Coronavirus disease (COVID 19) patient within 4 weeks before study drug administration
- Known to be other than negative for Severe acute respiratory syndrome coronavirus 2 (SARS Cov 2) antibody test at Screening
- Known to be other than negative for SARS Cov 2 polymerase chain reaction (PCR) test at Screening or Baseline
- History of retinopathy, maculopathy or macular degeneration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cohort 2: E6742 200 mg or Placebo
Participants will receive E6742 200 mg or E6742-matched placebo, tablets, orally, twice daily for 6 days under fasted conditions and once on Day 7 in the morning.
|
E6742 tablets.
E6742-matched placebo tablets.
|
EXPERIMENTAL: Cohort 3: E6742 400 mg or Placebo
Participants will receive E6742 400 mg or E6742-matched placebo, tablets, orally, twice daily for 6 days under fasted conditions and once on Day 7 in the morning.
|
E6742 tablets.
E6742-matched placebo tablets.
|
EXPERIMENTAL: Cohort 1: E6742 100 milligram (mg) or Placebo
Participants will receive E6742 100 mg or E6742-matched placebo, tablets, orally, twice daily for 6 days under fasted conditions and once on Day 7 in the morning.
|
E6742 tablets.
E6742-matched placebo tablets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 28 days after the last dose of study drug (approximately Day 35)
|
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs; laboratory evaluation for hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and the performance of physical examinations.
|
Baseline up to 28 days after the last dose of study drug (approximately Day 35)
|
Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 1
Time Frame: Day 1: 0-12 hours
|
Day 1: 0-12 hours
|
|
tmax: Time at Which the Highest Drug Plasma Concentration Occurs for E6742 and its Metabolite (ER-001132963) on Day 1
Time Frame: Day 1: 0-12 hours
|
Day 1: 0-12 hours
|
|
AUC(0-12h): Area Under the Plasma Concentration-time Curve From Zero Time to 12 Hours Postdose for E6742 and its Metabolite (ER-001132963) on Day 1
Time Frame: Day 1: 0-12 hours
|
Day 1: 0-12 hours
|
|
AUC Metabolite to E6742 Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 1
Time Frame: Day 1: 0-12 hours
|
Day 1: 0-12 hours
|
|
Css,max: Maximum Observed Plasma Concentration at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
tss,max: Time at Which the Highest Drug Plasma Concentration Occurs at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
Css,av: Average Steady State Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
AUC(0-12hr): Area Under the Plasma Concentration-time Curve Within a Dosing Interval at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-12 hours
|
Day 7: 0-12 hours
|
|
t1/2: Terminal Elimination Phase Half-life for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
CLss/F: Apparent Total Clearance at Steady State for E6742 on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
Vss/F: Apparent Volume of Distribution at Steady State for E6742 on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
PTF: Peak-trough Fluctuation for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
Accumulation Ratio for Cmax and AUC for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
Metabolite to E6742 AUC Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 7
Time Frame: Day 7: 0-168 hours
|
Day 7: 0-168 hours
|
|
AUC(0-12hr)ss: Area Under the Plasma Concentration-time Curve Within a Dosing Interval at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Time Frame: Day 7: 0-12 hours
|
Day 7: 0-12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Corrected QT Interval (QTc) for E6742
Time Frame: Day 1 and 7: 0-12 hours
|
High precision method QT analysis (HPQT) will be performed using data extracted from the 12-hour holter recording obtained from the morning of day 1 (predose) through 12 hours after dosing, the morning of day 7 (predose) through 12 hours after dosing.
|
Day 1 and 7: 0-12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 28, 2020
Primary Completion (ACTUAL)
June 21, 2021
Study Completion (ACTUAL)
June 21, 2021
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (ACTUAL)
December 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 14, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E6742-J081-005
- jRCT2031200316 (REGISTRY: jRCT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on E6742
-
Eisai Co., Ltd.CompletedLupus Erythematosus, SystemicJapan
-
Eisai Inc.CompletedHealthy ParticipantsUnited States