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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00945932 | A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics | PHASE2 | COMPLETED | 37 | — | — | Jul 1, 2009 | Dec 1, 2009 | Oct 12, 2016 | 8 | Germany |
| NCT00857857 | A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics | PHASE2 | COMPLETED | 24 | — | — | Feb 16, 2009 | Nov 3, 2009 | Feb 20, 2018 | 4 | Germany |
| NCT01160003 | A Blinded, Dose Ascending Study to Assess the Pharmacokinetics, Safety and Tollerability of Repeat Inhaled Doses of Nebulised GW870086X in Healthy Adult Male Volunteers. | PHASE1 | COMPLETED | 12 | — | — | Jul 29, 2010 | Nov 5, 2010 | Jun 14, 2017 | 1 | Germany |
| NCT00549497 | A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers | PHASE1 | COMPLETED | 36 | — | — | Sep 1, 2007 | Jan 1, 2008 | Feb 3, 2017 | 1 | Australia |
| NCT00483899 | Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects | PHASE1 | COMPLETED | 20 | — | — | Oct 7, 2005 | Dec 15, 2006 | Sep 29, 2017 | 3 | United Kingdom |
Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).
| Arm | Type | Description |
|---|---|---|
| 28 day repeat dose | EXPERIMENTAL | - |
| 13 day repeat dose | EXPERIMENTAL | - |
| Treatment Period 1 | EXPERIMENTAL | 5mg of GW870086X or placebo will be given once daily for 14 days. |
| Treatment Period 2 | EXPERIMENTAL | GW870086X (5mg or 8.75mg) or placebo will be given once daily for 14 days. In a randomised dose escalating manor following on from treatment period 1. |
| Treatment Period 3 | EXPERIMENTAL | 8.75mg of GW870086X or placebo will be given once daily for 14 days. |
| GW870086X | OTHER | - |
| Cohort 1: Part A | EXPERIMENTAL | Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo. |
| Cohort 2: Part A | EXPERIMENTAL | Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo. |
| Part B | EXPERIMENTAL | Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo. |
| Name | Type | Description |
|---|---|---|
| GW870086X | DRUG | Investigational product |
| Placebo | DRUG | Placebo control |
| FP | DRUG | Positive control |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or p...