Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2376497 · 1 trial · 1 indication
Adverse events, laboratory parameters, ECGs, and vital signs
Pharmacokinetics parameters: AUCs, Cmax, tmax, elimination half-life (t½), lag time (tlag), apparent clearance (CL/F) and apparent volume of distribution (V/F), area under the plasma drug concentration versus time curve on Days 1 through end of study (up to 70 Days)
| Arm | Type | Description |
|---|---|---|
| GSK2376497 | ACTIVE_COMPARATOR | single dose escalation or multiple-dose titration |
| 0.9% sodium chloride | PLACEBO_COMPARATOR | placebo injection |
| Name | Type | Description |
|---|---|---|
| GSK2376497 | DRUG | GSK2376497 Active Comparator |
| 0.9% sodium chloride | DRUG | 0.9% sodium chloride Placebo Comparator |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and Holter monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range f...
GSK2376497 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The molecular target of GSK2376497 has not been disclosed. It is being studied as a potential treatment for Type 2 Diabetes Mellitus, but its specific mechanism of action is not publicly available.
GSK2376497 is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability.
GSK2376497 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not received regulatory approval and is still being evaluated for safety and tolerability.
GSK2376497 has one completed Phase 1 clinical trial, NCT01545570, titled 'A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers.' This trial enrolled 82 participants in the United States and was placebo-controlled, randomized, and double-blind.
The clinical trial NCT01545570 refers to GSK2374697, which appears to be a variant name for GSK2376497. The study evaluates the safety and tolerability of the compound in healthy volunteers for Type 2 Diabetes Mellitus.