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GW784568X · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment period 1 | EXPERIMENTAL | In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 2 | EXPERIMENTAL | In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 3 | EXPERIMENTAL | In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 4 | PLACEBO_COMPARATOR | In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Name | Type | Description |
|---|---|---|
| GW784568X | DRUG | GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg. |
| Fluticasone propionate | DRUG | Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg. |
| Placebo | DRUG | Matching Placebo to GW784568X as aqueous nasal spray. |
Inclusion criteria: * Healthy with exception of seasonal rhinitis. May also have mild asthma. * Weight greater than or equal to 50kg * Non-smoker for at least 12 months Exclusion criteria: * History of frequent nosebleeds * Have participated in another trial in the last 30 days. * Have donated bl...
GW784568X is an investigational small molecule being developed for perennial allergic rhinitis, a chronic nasal condition caused by year-round allergens. It was studied in a Phase 1 clinical trial to evaluate its effects on allergic rhinitis symptoms. The drug is not approved and remains in early clinical development.
GW784568X is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted a Phase 1 trial of the drug in Germany to assess its safety and effects on allergic rhinitis symptoms.
GW784568X is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a placebo-controlled study in 45 male subjects. The drug is investigational and has not been approved by regulatory authorities for any use.
GW784568X has one completed clinical trial, registered as NCT00404586. This Phase 1 study, titled 'Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber,' enrolled 45 male participants aged 18 years and older in Germany.
GW784568X is the primary name for this investigational compound. No alternative names have been reported in the available clinical trial information. It is a distinct small molecule being studied for perennial allergic rhinitis.