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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01853852 | A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects | PHASE1 | COMPLETED | 14 | — | — | Sep 1, 2011 | Dec 1, 2011 | Dec 18, 2013 | 1 | Australia |
AUC, Cmax, tmax, Tlast , t1/2, CL/F, Vz/F
Ae, CLr, %Fx
| Arm | Type | Description |
|---|---|---|
| 50 mg | EXPERIMENTAL | GR181413A/AT1001 |
| 150 mg | EXPERIMENTAL | GR181413A/AT1001 |
| 450 mg | EXPERIMENTAL | GR181413A/AT1001 |
| Placebo | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| GR181413A/AT1001 solution | DRUG | Powder for reconstitution |
| GR181413A/AT1001 capsule | DRUG | Size 2, hard gelatin capsule, white opaque / blue opaque |
| Potable water | OTHER | Matched, Size 2, hard gelatin capsule, white opaque/blue opaque |
| Placebo capsule | DRUG | Solution matched |
Inclusion Criteria: 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range...