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A Study to Assess the Safety and Tolerability of E6742 in Japanese Healthy Adult Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04683185
Recruitment Status : Completed
First Posted : December 24, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: E6742 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : December 28, 2020
Actual Primary Completion Date : June 21, 2021
Actual Study Completion Date : June 21, 2021
Arms and Interventions
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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.
 Drug: E6742
E6742 tablets.

Drug: Placebo
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.
 Drug: E6742
E6742 tablets.

Drug: Placebo
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.
 Drug: E6742
E6742 tablets.

Drug: Placebo
E6742-matched placebo tablets.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 1 [ Time Frame: Day 1: 0-12 hours ]
  3. 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 ]
  4. 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 ]
  5. AUC Metabolite to E6742 Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 1 [ Time Frame: Day 1: 0-12 hours ]
  6. 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 ]
  7. 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 ]
  8. Css,av: Average Steady State Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  9. 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 ]
  10. 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 ]
  11. t1/2: Terminal Elimination Phase Half-life for E6742 and its Metabolite (ER-001132963) on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  12. CLss/F: Apparent Total Clearance at Steady State for E6742 on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  13. Vss/F: Apparent Volume of Distribution at Steady State for E6742 on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  14. PTF: Peak-trough Fluctuation for E6742 and its Metabolite (ER-001132963) on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  15. Accumulation Ratio for Cmax and AUC for E6742 and its Metabolite (ER-001132963) on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  16. Metabolite to E6742 AUC Ratio Following Molecular Weight Correction to E6742 Equivalents on Day 7 [ Time Frame: Day 7: 0-168 hours ]
  17. 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 ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Body mass index (BMI) >=18.5 and less than (<) 25.0 kilogram per meter square (kg/m^2) at Screening

Exclusion Criteria:

  1. Females who are breastfeeding or pregnant at Screening or Baseline

  2. 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
  3. 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)
  4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection within 4 weeks before dosing
  5. Any history of gastrointestinal surgery that may affect PK profiles of E6742 at Screening
  6. 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
  7. 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
  8. Persistent systolic blood pressure >130 millimeter of mercury (mmHg) or diastolic blood pressure >85 mmHg diastolic at Screening or Baseline
  9. Heart rate less than 45 or more than 100 beats per min at Screening or Baseline
  10. 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)
  11. Any lifetime history of psychiatric disease
  12. Any current psychiatric symptoms as indicated by a standard screening tool (Patient Health Questionnaire 9 [PHQ 9])
  13. 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)
  14. History of autoimmune disease or immunodeficiency
  15. Known to be positive for tuberculosis test (T-spot. TB Test) at Screening
  16. Received immunoglobulin or blood preparation within 6 months before the study treatment
  17. Received inoculation within 4 weeks before the study treatment (8 weeks before in case of live or attenuated vaccine)
  18. Family living together or cohabitant of a patient with an influenza virus infection
  19. In contact with Coronavirus disease (COVID 19) patient within 4 weeks before study drug administration
  20. Known to be other than negative for Severe acute respiratory syndrome coronavirus 2 (SARS Cov 2) antibody test at Screening
  21. Known to be other than negative for SARS Cov 2 polymerase chain reaction (PCR) test at Screening or Baseline
  22. History of retinopathy, maculopathy or macular degeneration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683185


Locations
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Japan
Eisai Trial Site #1
Bunkyō-Ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
More Information
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Additional Information:

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT04683185    
Other Study ID Numbers: E6742-J081-005
jRCT2031200316 ( Registry Identifier: jRCT )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
E6742
Healthy participants
Pharmacokinetics