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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449799 | An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Jul 13, 2011 | Sep 21, 2011 | Jul 28, 2017 | 1 | United Kingdom |
Maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve, and apparent terminal phase half-life (t1/2)\] for GSK961081 and fluticasone propionate
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | In period 1, subjects will be administered GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers in period 2. In period 3 and period 4, the subjects will receive fluticasone propionate and GSK961081 respectively. |
| Sequence 2 | EXPERIMENTAL | In period 1, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by administration of GSK961081 in period 2. In period 3 and period 4, the subjects will receive GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of fluticasone propionate respectively. |
| Sequence 3 | EXPERIMENTAL | In period 1, subjects will be administered GSK961081 followed by administration of fluticasone propionate in period 2. In period 3, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by GSK961081/fluticasone propionate blend via Diskus inhaler in period 4. |
| Sequence 4 | EXPERIMENTAL | In period 1, subjects will be administered fluticasone propionate followed by the administration of GSK961081/fluticasone propionate blend via Diskus inhaler in period 2. The subjects will receive GSK961081 in period 3 and concurrent administration of GSK961081 and fluticasone propionate in period 4. |
| Name | Type | Description |
|---|---|---|
| GSK961081 800 microgram dose | DRUG | To be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers |
| Fluticasone Propionate 500 microgram dose | DRUG | To be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers |
| GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately | DRUG | To be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation |
| GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend | DRUG | To be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers |
Inclusion Criteria: 1. Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent. 2. Healthy as determined by the Investigator based on a medical evaluation including medical history, physical examination, laboratory tests and lung function testing. A subj...