Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW870086X · 5 trials · 1 indication
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...
GW870086X is an investigational small molecule being developed for the treatment of asthma. It is administered by inhalation and has been studied in patients with mild to moderate asthma as well as in healthy volunteers. The drug is still in clinical development and has not been approved by regulatory authorities.
GW870086X is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company has conducted multiple clinical trials to evaluate the drug's safety, tolerability, and effects on lung function in asthmatic patients.
GW870086X is in Phase 2 clinical development for asthma. The drug has completed five clinical trials, including Phase 1 and Phase 2 studies, with a total enrollment of 129 participants. All trials have been completed, and the drug remains investigational.
GW870086X has been studied in several completed clinical trials, including NCT00483899, NCT00549497, NCT00945932, and NCT01160003. These trials evaluated the drug's effects on lung function, steroid hormone levels, pharmacokinetics, safety, and tolerability in healthy volunteers and patients with asthma.
GW870086X is a small molecule administered by inhalation for the treatment of asthma. The specific molecular target of the drug has not been disclosed in the available clinical trial information. The drug is being studied for its effects on lung function and safety in asthmatic patients.