Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02209766 | A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids) | PHASE1 | COMPLETED | 86 | — | — | Aug 1, 2014 | Nov 1, 2014 | May 17, 2016 | 1 | Japan |
Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)
| Arm | Type | Description |
|---|---|---|
| D5884 | EXPERIMENTAL | D5884 capsule, Per oral(po) |
| Placebo | PLACEBO_COMPARATOR | Placebo capsule, po |
| Name | Type | Description |
|---|---|---|
| D5884 | DRUG | 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian |
| Placebo | DRUG | 1. st cohort: Dose 1(2g) D5884(n=3) in Japanese 2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese |
Inclusion Criteria: 1. Healthy adult male, 20 to 45 years of age (inclusive) 2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2 for Caucasian subjects. BMI calculations to be conducted on height and weight values obtained at Visit 1 3. Medically healthy with cli...