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Completed

NCT Number: NCT04683185

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

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.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eisai Trial Site #1

Bunkyō-Ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E6742

Drug

E6742 tablets.

Placebo

Drug

E6742-matched placebo tablets.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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