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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00372112 | A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 68 | — | — | Nov 3, 2006 | May 10, 2007 | Apr 2, 2018 | 14 | Australia, Bulgaria +4 |
| NCT00347139 | Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients | PHASE2 | COMPLETED | 55 | — | — | May 23, 2006 | Jan 10, 2007 | Sep 14, 2017 | 7 | Germany, New Zealand +3 |
| NCT01286831 | A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444. | PHASE1 | COMPLETED | 6 | — | — | May 18, 2010 | Jul 9, 2010 | Jun 20, 2017 | 1 | Netherlands |
| NCT00711126 | A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection | PHASE1 | COMPLETED | 9 | — | — | Oct 21, 2008 | Dec 17, 2008 | Jul 21, 2017 | 1 | United Kingdom |
| NCT00964249 | Phase I Study of GW642444M in Healthy Japanese Male Subjects | PHASE1 | COMPLETED | 32 | — | — | Sep 20, 2008 | Dec 1, 2008 | Aug 3, 2017 | 1 | Japan |
| NCT00702910 | A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients | PHASE1 | COMPLETED | 24 | — | — | Apr 27, 2008 | Oct 4, 2008 | Aug 10, 2017 | 3 | Australia, New Zealand |
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.
| Arm | Type | Description |
|---|---|---|
| 100 mcg GW642444H | ACTIVE_COMPARATOR | Twice daily in the morning. |
| 400 mcg GW642444H | ACTIVE_COMPARATOR | Twice daily in the morning. |
| 50 mcg salmeterol | ACTIVE_COMPARATOR | Twice daily. |
| placebo | PLACEBO_COMPARATOR | Twice daily |
| GW642444 | EXPERIMENTAL | - |
| Salmeterol | ACTIVE_COMPARATOR | - |
| [14C]GW642444 | EXPERIMENTAL | Single 200μg dose of \[14C\]GW642444 given on Day 1. |
| Arm 1 | EXPERIMENTAL | HVTs |
| Arm 2 | EXPERIMENTAL | HVTs |
| Arm 3 | EXPERIMENTAL | HVTs |
| Arm 4 | EXPERIMENTAL | HVTs |
| Arm 5 | EXPERIMENTAL | HVTs |
| Arm 6 | EXPERIMENTAL | HVTs |
| LABA | EXPERIMENTAL | After randomization subject will inhale either 12.5 microgram or 25 microgram GW642444M once daily for 7 days. |
| GW642444M/lactose | EXPERIMENTAL | GW642444M/lactose 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design) |
| GW642444M/MgSt | EXPERIMENTAL | GW642444M/MgSt 6.25, 25 and 100 microgram, single inhaled dose for two days treatment in each treatment sequence (crossover design) |
| Name | Type | Description |
|---|---|---|
| GW642444 | DRUG | GW642444H |
| Placebo | OTHER | Placebo administered twice daily |
| GW642444 (25, 100 & 400 mcg/day) | DRUG | 25, 100 and 400mcg/dose |
| Salmeterol 50mcg | DRUG | Salmeterol 50mcg |
| [14C]GW642444 | DRUG | Single 200μg dose of \[14C\]GW642444 given on Day 1. |
| Magnesium Stearate | DRUG | Magnesium Stearate |
Inclusion criteria: * females must be of non-childbearing potential * moderately severe COPD Exclusion criteria: * Subjects with a main diagnosis of asthma * subjects with poorly controlled COPD * subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological diseas...