Healthy VolunteersPhase 1NCT04683185
A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants
A Phase 1 study testing E6742 in people with Healthy Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E6742
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 28 Dec 2020to 21 Jun 2021
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- E6742, Placebo
- Keywords
- E6742, Healthy participants, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6742Drug
E6742 tablets.
PlaceboDrug
E6742-matched placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2: E6742 200 mg or Placebo | Experimental | 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. Receives: Drug: E6742; Drug: Placebo |
| Cohort 3: E6742 400 mg or Placebo | Experimental | 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. Receives: Drug: E6742; Drug: Placebo |
| Cohort 1: E6742 100 milligram (mg) or Placebo | Experimental | 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. Receives: Drug: E6742; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1: 0-12 hours
AUC Metabolite to E6742 Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 1
Measured: Day 1: 0-12 hours
Css,max: Maximum Observed Plasma Concentration at Steady State for E6742 and its Metabolite (ER-001132963) on Day 7
Measured: 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
Measured: Day 7: 0-168 hours
Css,av: Average Steady State Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Measured: 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
Measured: 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
Measured: Day 7: 0-12 hours
t1/2: Terminal Elimination Phase Half-life for E6742 and its Metabolite (ER-001132963) on Day 7
Measured: Day 7: 0-168 hours
CLss/F: Apparent Total Clearance at Steady State for E6742 on Day 7
Measured: Day 7: 0-168 hours
Vss/F: Apparent Volume of Distribution at Steady State for E6742 on Day 7
Measured: Day 7: 0-168 hours
PTF: Peak-trough Fluctuation for E6742 and its Metabolite (ER-001132963) on Day 7
Measured: Day 7: 0-168 hours
Accumulation Ratio for Cmax and AUC for E6742 and its Metabolite (ER-001132963) on Day 7
Measured: Day 7: 0-168 hours
Metabolite to E6742 AUC Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 7
Measured: 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
Measured: Day 7: 0-12 hours
Secondary outcomes (1)
Change From Baseline in Corrected QT Interval (QTc) for E6742
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.
Measured: Day 1 and 7: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start28 Dec 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683185
- Sponsor's protocol ID
- E6742-J081-005
- Other IDs
- jRCT2031200316
- Status last verified
- May 2021
- First submitted
- 21 Dec 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Japanese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04683185
- Acronym / sponsor ID
- E6742-J081-005
- Conditions
- Healthy Volunteers
- Keywords
- E6742, Healthy participants, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2: E6742 200 mg or Placebo | Experimental | Drug: E6742, Drug: PlaceboParticipants 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. |
| Cohort 3: E6742 400 mg or Placebo | Experimental | Drug: E6742, Drug: PlaceboParticipants 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. |
| Cohort 1: E6742 100 milligram (mg) or Placebo | Experimental | Drug: E6742, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (29 listed)
- Females who are breastfeeding or pregnant at Screening or Baseline
- 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 (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
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 |
|---|---|---|
| E6742E6742 tablets. | Drug | Cohort 1: E6742 100 milligram (mg) or Placebo, Cohort 2: E6742 200 mg or Placebo, Cohort 3: E6742 400 mg or Placebo |
| PlaceboE6742-matched placebo tablets. | Drug | Cohort 1: E6742 100 milligram (mg) or Placebo, Cohort 2: E6742 200 mg or Placebo, Cohort 3: E6742 400 mg or Placebo |
Primary outcome
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.
Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 1
Time frame: 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
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
AUC Metabolite to E6742 Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 1
Time frame: 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
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
Css,av: Average Steady State Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: 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
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
t1/2: Terminal Elimination Phase Half-life for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: 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
Vss/F: Apparent Volume of Distribution at Steady State for E6742 on Day 7
Time frame: 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
Accumulation Ratio for Cmax and AUC for E6742 and its Metabolite (ER-001132963) on Day 7
Time frame: 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
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
1 secondary outcome
Change From Baseline in Corrected QT Interval (QTc) for E6742
Time frame: Day 1 and 7: 0-12 hours
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 20 Jul 2021.
- Study results will be disclosed on the jRCT registry record.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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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 E6742 in people with Healthy Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
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 29 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 20 Jul 2021. 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 Japan. 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?
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)). The study lists 17 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 20 Jul 2021.