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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 being developed for seasonal allergic rhinitis, also known as hay fever. It is an oral small molecule studied in allergen challenge chamber settings, where participants are exposed to allergens under controlled conditions to assess treatment response. All three of its listed clinical trials enrolled adults with seasonal allergic rhinitis or healthy male volunteers.
GSK835726 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three clinical trials of the compound, conducted in Germany and the United Kingdom. GSK holds the asset as part of its respiratory therapeutic area pipeline.
GSK835726 has completed Phase 2 clinical development. Two Phase 2 allergen challenge chamber studies were run in Germany, and one Phase 1 study was conducted in the United Kingdom. All three trials are listed as completed, and no trials are currently active.
GSK835726 has been studied in three completed trials: NCT00972504, a Phase 2 proof of concept allergen challenge chamber study in Hannover; NCT00851344, a Phase 2 single dose allergen challenge chamber study versus placebo; and NCT00605852, a Phase 1 study of an oral anti-histamine in healthy male subjects.
Across the three completed trials, 137 participants have been enrolled in GSK835726 studies. The two Phase 2 allergen challenge chamber trials each enrolled 54 participants, and the Phase 1 study enrolled 29 healthy male subjects. The trials were randomized, double blind, and placebo controlled.