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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449838 | Phase I Study of Colistin Methanesulfonate Sodium | PHASE1 | COMPLETED | 22 | — | — | Oct 23, 2010 | Dec 9, 2010 | Jul 21, 2017 | 1 | Australia |
Maximum drug concentration (Cmax), Time of occurrence of Cmax (tmax), Terminal phase half-life(t1/2), Area under the concentration-time curve: AUC(0-inf), AUC(0-12), AUC(0-last), Clearance (CL), Fraction of urinary excretion (fe), Accumulation ratio (Ro and Rs).
Vital signs, ECGs, clinical laboratory test and adverse events.
Urinary β2-microglobulin, N-acetyl-β-D-glucosaminidase and creatinine clearance (CLcr).
Vital signs, ECGs, clinical laboratory test and adverse events.
Vital signs, ECGs, clinical laboratory test and adverse events.
| Arm | Type | Description |
|---|---|---|
| Saline | PLACEBO_COMPARATOR | Subjects were administered single dose or twice daily for 2.5 days repeat dose of placebo by the intravenous route. |
| Colistimethate sodium | EXPERIMENTAL | 2.5 milligrams (mg)/kilogram (kg) of CMS-NA (as colistin activity or 75,000 International Unit/kg) was administered as single dose or twice daily for 2.5 days repeat dose by the intravenous route. |
| Name | Type | Description |
|---|---|---|
| Colistimethate sodium | DRUG | active |
| Saline | DRUG | placebo |
\<Inclusion Criteria\> A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardia...