Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
New formulation, Current formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving new formulation in blank test group | EXPERIMENTAL | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in blank test group | ACTIVE_COMPARATOR | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving new formulation in pre-test group | EXPERIMENTAL | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in pre-test group | ACTIVE_COMPARATOR | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving new formulation in main-test group | EXPERIMENTAL | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Subjects receiving current formulation in main-test group | ACTIVE_COMPARATOR | Eligible subjects will receive acyclovir cream 5 % following single topical application. |
| Name | Type | Description |
|---|---|---|
| New formulation | DRUG | New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan |
| Current formulation | DRUG | Current formulation of Aciclovir Cream 5% in Japan |
Inclusion Criteria: * Healthy Japanese adult males between 20 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-...
GSK561679 is an investigational drug being studied for use in depressive disorder and anxiety disorders. It was evaluated in a Phase 1 clinical trial in healthy volunteers to investigate its effects on brain activation during emotional processing. The drug is still in clinical development and has not been approved by regulatory authorities.
GSK561679 targets the corticotropin-releasing factor receptor, which is involved in the body's stress response. By modulating this receptor, the drug may influence emotional processing and potentially affect symptoms of depression and anxiety. This mechanism was studied in a Phase 1 trial measuring brain activation during emotional tasks.
GSK561679 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company conducted a Phase 1 clinical trial of the drug in the United States to evaluate its effects on brain activity in healthy female volunteers.
GSK561679 is in Phase 1 clinical development. A Phase 1 trial with the identifier NCT00513565 was completed, involving 22 healthy female volunteers in the United States. The drug is investigational and has not received FDA approval for any indication.
GSK561679 was studied in one completed Phase 1 clinical trial, NCT00513565, titled "A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers." The trial enrolled 22 healthy female participants aged 18 years and older in the United States.
GSK561679 is a distinct investigational compound and is not known to be the same as any other marketed drug. It is being developed specifically for potential use in depressive and anxiety disorders, and its development is separate from other GSK products.