A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Patients
Overview
- Phase
- Phase 1
- Intervention
- E6742
- Conditions
- Lupus Erythematosus, Systemic
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 26
- Locations
- 12
- Primary Endpoint
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary purpose of the study is to evaluate the safety and tolerability of multiple oral doses of E6742 in participants with systemic lupus erythematosus (SLE).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years at the time of written informed consent
- •Body mass index (BMI) \>=15 kilogram per square meter (kg/m\^2) and less than (\<) 30 kg/m\^2 at screening
- •Diagnosed with SLE according to 2019 The European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) classification criteria, Systemic Lupus International Collaborating Clinics Disease Index (SLICC) classification criteria (2012 version), or 1997 revised ACR classification criteria at least 6 months before the informed consent
- •Meets at least one of the following criteria at screening:
- •Antinuclear antibody positive (\>=1:80)
- •Anti-double stranded deoxyribonucleic acid (DNA) antibody positive
- •Anti-smith antibody positive
Exclusion Criteria
- •Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin \[ß-hCG\] or human chorionic gonadotropin \[hCG\] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
- •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 (if it is their preferred and usual lifestyle)
- •an intrauterine device or intrauterine hormone-releasing system (IUS)
- •a contraceptive implant
- •an oral contraceptive (Participant must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of the oral contraceptive throughout the study and for 28 days after study drug discontinuation)
- •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
- •Participants on an oral contraceptive must use an additional barrier method throughout the study and 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 (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Approved or certificated for drugs or medical devices in Japan
Arms & Interventions
Cohort 1: E6742 100 mg or Placebo
Participants will receive E6742 100 milligram (mg) tablet or E6742-matched placebo tablet, orally, twice daily for up to 85 days.
Intervention: E6742
Cohort 1: E6742 100 mg or Placebo
Participants will receive E6742 100 milligram (mg) tablet or E6742-matched placebo tablet, orally, twice daily for up to 85 days.
Intervention: Placebo
Cohort 2: E6742 200 mg or Placebo
Participants will receive E6742 200 mg tablets (two tablets of each 100 mg) or E6742-matched placebo tablets, orally, twice daily for up to 85 days.
Intervention: E6742
Cohort 2: E6742 200 mg or Placebo
Participants will receive E6742 200 mg tablets (two tablets of each 100 mg) or E6742-matched placebo tablets, orally, twice daily for up to 85 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Screening up to 28 days after the last dose of study drug at Day 85 (up to approximately 1 year 5 months)
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); the performance of physical examinations and chest X-ray test.
Secondary Outcomes
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E6742 and its Metabolite (ER-001132963) on Days 1 and 15(Days 1 and 15: 0-6 hours post-dose)
- Cmax: Maximum Observed Plasma Concentration for E6742 and its Metabolite (ER-001132963) on Days 1 and 15(Days 1 and 15: 0-6 hours post-dose)
- AUC(0-6Hours): Area Under the Plasma Concentration Versus Time Curve from Time 0 to 6 Hours for E6742 and its Metabolite (ER-001132963) on Days 1 and 15(Days 1 and 15: 0-6 hours post-dose)