Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK drug · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 | OTHER | Single dose escalation |
| Part 2 | OTHER | Pharmacodynamic assessment |
| Name | Type | Description |
|---|---|---|
| GSK drug | DRUG | GSK drug |
| Placebo | OTHER | Placebo |
| Lamictal | OTHER | Positive control |
Part 1 Inclusion Criteria: * Healthy male subjects aged between 18 and 65 yrs and female (of non-child bearing potential) subjects aged between 18 and 50 years. Part 2 Inclusion Criteria: * right-handed healthy male subjects aged between 18 and 65 years. Parts 1 \& 2 Inclusion Criteria: * body ...
GSK drug is an investigational small molecule being studied for the treatment of bipolar disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and tolerability in clinical trials.
Biogen Inc. (NASDAQ: BIIB) is the developer of GSK drug. The company is conducting clinical research on this investigational small molecule for bipolar disorder. The drug is currently in Phase 1 development.
GSK drug is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed to evaluate the drug's effects in healthy volunteers.
GSK drug has one completed Phase 1 clinical trial, identified as NCT00488566. This trial was a single dose escalation study that examined the drug's effect on resting motor threshold in healthy volunteers. The trial enrolled 50 participants in the United Kingdom.
GSK drug is the name used in clinical development for this investigational compound. No alternative names have been established for this drug in the available information. It is being developed by Biogen Inc. for bipolar disorder.