Lupus Erythematosus, Systemic
Conditions
Keywords
E6742
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).
Interventions
DRUGE6742
E6742 tablet.
OTHERPlacebo
E6742-matching placebo tablet.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Body mass index (BMI) \>=15 kilogram per square meter (kg/m\^2) and less than (\<) 30 kg/m\^2 at screening 3. 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 4. 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
1. 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 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 (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 3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Countries
Japan
Outcome results
None listed