Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK961081 800 microgram dose · 1 trial · 1 indication
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...
GSK961081 800 microgram dose is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development and has been studied in a completed trial involving healthy volunteers to assess its pharmacokinetics.
GSK961081 800 microgram dose is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for chronic obstructive pulmonary disease.
GSK961081 800 microgram dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its pharmacokinetics in healthy volunteers.
GSK961081 800 microgram dose has been studied in one completed Phase 1 clinical trial, NCT01449799, titled 'An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers.' The trial enrolled 24 participants in the United Kingdom and was randomized, double-blind, and controlled.
GSK961081 800 microgram dose is a specific dose strength of the investigational drug GSK961081. The 800 microgram dose has been studied in a Phase 1 clinical trial for chronic obstructive pulmonary disease, and the trial also investigated its combination with fluticasone propionate.