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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00469040 | Safety, Blood Levels and Effects of GW642444 | PHASE1 | COMPLETED | 36 | — | — | Feb 28, 2007 | Apr 16, 2007 | Aug 4, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| GW642444M 25mcg | EXPERIMENTAL | In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg. |
| GW642444M 50mcg | EXPERIMENTAL | Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1. |
| GW642444M 100mcg | EXPERIMENTAL | In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg. |
| GW642444M 200mcg | EXPERIMENTAL | Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2. |
| GW642444M 400mcg | EXPERIMENTAL | Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3. |
| Name | Type | Description |
|---|---|---|
| GW642444M for 14 days | DRUG | M salt |
Inclusion criteria: * healthy males and females (of non-childbearing potential) aged 18-55 * body weight \>50kg with BMI 19-29.9 kg/m2 * normal ECG recording * non-smoker Exclusion criteria: * high blood pressure (above 140/90 mmHg) * pulse outside range 45 - 90 bpm * history of breathing problem...