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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01428479 | Phase1 Study of GR121167, Single and Multiple Dose Study in Healthy Japanese Males | PHASE1 | COMPLETED | 18 | — | — | Jan 7, 2011 | Apr 4, 2011 | Jul 21, 2017 | 1 | Japan |
Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (Cτ), accumulation ratios (Ro, Rs)
vital signs, ECGs, clinical laboratory tests, and adverse events
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | EXPERIMENTAL | In Arm A subjects will receive 100 mg of GR121167 in Period 1 and 300 mg of GR121167 in Period 2. In Period 3 subject will receive single doses of placebo on Day 1 and multiple doses of placebo from Day 3 to Day 8 |
| Treatment Arm B | EXPERIMENTAL | In Arm B subjects will receive 100 mg of GR121167 in Period 1 and placebo in Period 2. In Period 3 subject will receive 600 mg of GR121167 as single dose on Day 1 and multiple doses of GR121167 from Day 3 to Day8 |
| Treatment Arm C | EXPERIMENTAL | In Arm C subjects will receive placebo in Period 1, 300 mg of GR121167 in Period 2. In period 3 subject will receive 600 mg of GR121167 single dose on Day 1 and multiple doses from Day 3 to Day 8 |
| Name | Type | Description |
|---|---|---|
| GR121167 Solution | DRUG | GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg |
| Placebo | DRUG | Placebo solution will be administered intravenously. |
Inclusion Criteria: 1. Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. 2. Japanese healthy m...