Approval Probability
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Adjusted LOA
ML Risk
GSK835726 · 3 trials · 1 indication
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.
| Arm | Type | Description |
|---|---|---|
| GSK835726 (10mg) | ACTIVE_COMPARATOR | 10mg oral dose |
| GSK1004723 (1000mcg) | ACTIVE_COMPARATOR | 1000mcg nasal spray solution |
| Cetirizine 10mg | ACTIVE_COMPARATOR | 10mg cetirizine as active comparator |
| placebo | PLACEBO_COMPARATOR | placebo |
| GSK835726 (50mg) | ACTIVE_COMPARATOR | 50mg oral dose |
| GSK835726 (100mg) | ACTIVE_COMPARATOR | 50mg oral dose |
| Subjects receiving treatment in cohort I | EXPERIMENTAL | Eligible subjects will receive three single doses of GSK835726 and one single dose of placebo in cohort I. |
| Subjects receiving GSK835726 in cohort II | EXPERIMENTAL | Eligible subjects will receive repeat doses of GSK835726 once daily for 7 days. |
| Subjects receiving placebo in cohort II | PLACEBO_COMPARATOR | Eligible subjects will receive repeat doses of placebo once daily for 7 days. |
| Subjects receiving treatment in cohort III | EXPERIMENTAL | Eligible subjects will receive two single doses of GSK835726 and one single dose of placebo in cohort III. |
| Name | Type | Description |
|---|---|---|
| GSK835726 10mg | DRUG | GSK835726 10mg tablet |
| GSK1004723 1000mcg | DRUG | GSK1004723 1000mcg nasal spray solution |
| Cetirizine 10mg | DRUG | Cetirizine 10mg active comparator |
| placebo | DRUG | placebo to match actives |
| GSK835726 (10mg) | DRUG | GSK835726 (10mg) tablet |
| GSK835726 (50mg) | DRUG | GSK835726 (50mg) tablet |
| GSK835726 (100mg) | DRUG | GSK835726 (100mg) tablet |
| Cetirizine (10mg) | DRUG | Cetirizine (10mg) tablet as positive control |
| GSK835726 | DRUG | GSK835726 will be available in single dose and repeat dose formulations. |
Inclusion Criteria: * Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. * Males or female using contraceptives * Aged 18 - 65 * Weight 50kg+, BMI 19-32 kg/m2 * Exhibit response to Challenge Chamber and skin prick test. * Non-smoker * Capab...
GSK835726 is an investigational small molecule being developed for seasonal allergic rhinitis. It is a Phase 2 oral anti-histamine studied in allergen challenge chamber trials. It is not approved and remains in clinical development.
GSK835726 is being developed by GSK plc, traded on the London Stock Exchange under the ticker GSK. The company has completed three clinical trials of the drug for seasonal allergic rhinitis.
GSK835726 is in Phase 2 clinical development. It has completed one Phase 1 and two Phase 2 trials, all of which are finished. The drug is investigational and not yet approved.
GSK835726 has completed three trials: NCT00605852, a Phase 1 study in healthy male subjects; NCT00851344, a Phase 2 allergen challenge chamber study; and NCT00972504, a Phase 2 proof of concept study. All trials were placebo-controlled and double-blind.
GSK835726 is an oral anti-histamine, meaning it works by blocking the effects of histamine, a chemical involved in allergic reactions. It is being studied for its ability to relieve symptoms of seasonal allergic rhinitis.