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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00400660 | A First Time In Human Study To Assess The Compound GSK615915 | PHASE1 | COMPLETED | 46 | — | — | Nov 23, 2005 | Jul 3, 2006 | Sep 29, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving treatment sequence 1: Part 1 | EXPERIMENTAL | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving treatment sequence 2: Part 1 | EXPERIMENTAL | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
| Subjects receiving treatment sequence 1: Part 2 | EXPERIMENTAL | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving treatment sequence 2: Part 2 | EXPERIMENTAL | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
| Subjects receiving GSK615915A: Part 3 | EXPERIMENTAL | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving placebo: Part 3 | EXPERIMENTAL | Eligible subjects will receive placebo. |
| Name | Type | Description |
|---|---|---|
| GSK615915A | DRUG | GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler. |
| Placebo | DRUG | Subjects will also receive placebo inhaler. |
Inclusion Criteria: * Women of non-child bearing potential. * Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m² * The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history ...