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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00364273 | GSK159802 In Healthy Male Subjects And Asthmatics | PHASE1 | COMPLETED | 43 | — | — | Aug 24, 2005 | Jul 6, 2006 | Sep 29, 2017 | 2 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving treatment sequence 1 : Cohort 1 | EXPERIMENTAL | Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 2 : Cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 3 : Cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 4 : Cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 5 : Cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo. |
| Subjects receiving treatment sequence 1 : Cohort 2 | EXPERIMENTAL | Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD). |
| Subjects receiving treatment sequence 2 : Cohort 2 | EXPERIMENTAL | Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD. |
| Subjects receiving treatment sequence 3 : Cohort 2 | EXPERIMENTAL | Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol. |
| Subjects receiving treatment sequence 4 : Cohort 2 | EXPERIMENTAL | Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo. |
| Subjects receiving treatment sequence 1 : Cohort 3 | EXPERIMENTAL | Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 2 : Cohort 3 | EXPERIMENTAL | Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms. |
| Subjects receiving treatment sequence 3 : Cohort 3 | EXPERIMENTAL | Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol. |
| Subjects receiving treatment sequence 4 : Cohort 3 | EXPERIMENTAL | Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo. |
| Subjects receiving treatment sequence 5 : Cohort 3 | EXPERIMENTAL | Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo. |
| Name | Type | Description |
|---|---|---|
| GSK159802 | DRUG | GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler. |
| Placebo | DRUG | Subjects will receive placebo administered using DISKUS inhaler. |
| Salmeterol | DRUG | Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler. |
Inclusion criteria: * Body mass index within the range 18.5-29.9 (kg/m2) * Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years. Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients): ...