Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2140944 Lyophile · 1 trial · 1 indication
Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=\>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | Subject will receive GSK2140944 750mg IV every 12 hours (q12h; twice daily \[BID\]) on Day 1 and Day 2. Subject may switch to GSK2140944 1500mg orally (PO) q12h (BID) at investigator's decision or will continue to receive GSK2140944 750mg IV q12h (BID) from Day 3 to Day 10. |
| Treatment Group B | EXPERIMENTAL | Subject will receive GSK2140944 1000mg IV q12h (BID) on Day 1 and Day 2 . Subject may switch to GSK2140944 2000mg PO q12h (BID) at investigator's decision or will continue to receive GSK2140944 1000mg IV q12h (BID) from Day 3 to Day 10. |
| Treatment Group C | EXPERIMENTAL | Subject will receive GSK2140944 1000mg IV q8h (TID) on Day 1 and Day 2. Subject may switch to GSK2140944 2000mg PO q8h (TID) at investigator's decision or will continue to receive GSK2140944 1000mg IV q8h (TID) from Day 3 to Day 10. |
| Name | Type | Description |
|---|---|---|
| GSK2140944 Lyophile | DRUG | GSK2140944 Lyophile (pale yellow to grayish yellow cake) containing 750 mg of GSK2140944 (as free base) per vial for IV infusion. |
| GSK2140944 Capsules | DRUG | GSK2140944 500 mg capsules will be supplied as pink hard gelatin capsule with no external markings filled with slightly agglomerated pale yellow to grayish yellow powder. |
Inclusion Criteria: * The subject is an adult male at least 18 years of age or an adult female at least 18 years of age who meets one of the following criteria: A female of child-bearing potential who is either 1) sexually inactive by abstinence, 2) whose sole male partner has been sterilized, or 3...
GSK2140944 Lyophile is an investigational small molecule being developed for bacterial infections. It was studied in a Phase 2 trial for the treatment of suspected or confirmed Gram-positive acute bacterial skin and skin structure infections. The drug is still in clinical development and is not approved.
GSK2140944 Lyophile is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company conducted a Phase 2 clinical trial of the drug in the United States.
GSK2140944 Lyophile is in Phase 2 clinical development. A Phase 2 dose-ranging study has been completed, but the drug remains investigational and has not been approved for any use. No Phase 3 trials have been reported.
GSK2140944 Lyophile has one completed Phase 2 clinical trial, NCT02045797, a dose-ranging study in subjects with suspected or confirmed Gram-positive acute bacterial skin and skin structure infections. The trial enrolled 126 participants in the United States and was randomized, double-blind, and controlled.
GSK2140944 Lyophile is a formulation of the drug GSK2140944. The name "Lyophile" refers to a lyophilized (freeze-dried) form of the compound. In clinical trial NCT02045797, the drug is referred to as GSK2140944, indicating the same active pharmaceutical ingredient.