Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Colistimethate · 1 trial · 1 indication
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...
Colistimethate is an investigational small molecule being developed for the treatment of Pseudomonas infections. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under study to evaluate its safety and efficacy.
Colistimethate is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to assess the drug's potential as a treatment for Pseudomonas infections.
Colistimethate is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety, tolerability, and pharmacokinetics in humans.
Colistimethate has one completed Phase 1 clinical trial registered under NCT01449838, titled 'Phase I Study of Colistin Methanesulfonate Sodium.' This randomized, double-blind, placebo-controlled study enrolled 22 healthy male volunteers in Australia and evaluated the drug's safety and tolerability.
Yes, Colistimethate is also known as colistin methanesulfonate sodium, as reflected in the clinical trial title. The drug is being studied for its potential use in treating Pseudomonas infections, though it remains in early-stage clinical development.