Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00972504 | 723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover | PHASE2 | COMPLETED | 54 | — | — | Jun 1, 2009 | Aug 14, 2009 | Aug 2, 2017 | 1 | Germany |
| NCT00851344 | Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo | PHASE2 | COMPLETED | 54 | — | — | Sep 1, 2008 | Nov 1, 2008 | Nov 7, 2016 | 1 | Germany |
| NCT00605852 | Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects | PHASE1 | COMPLETED | 29 | — | — | Oct 29, 2007 | May 3, 2008 | Aug 21, 2017 | 1 | United Kingdom |
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...