Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK961081 SD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Period 2 | EXPERIMENTAL | GSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg |
| Cohort 1, period 1 | EXPERIMENTAL | Placebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg |
| Cohort 1, period 3 | EXPERIMENTAL | GSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg |
| Cohort 1, period 4 | EXPERIMENTAL | GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo |
| Cohort 2, period 1 | EXPERIMENTAL | Placebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, |
| Cohort 2, period 2 | EXPERIMENTAL | GSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg |
| Cohort 2, period 3 | EXPERIMENTAL | GSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg |
| Cohort 2, period 4 | EXPERIMENTAL | GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo |
| Cohort 3 | EXPERIMENTAL | GSK961081 100mcg or Placebo |
| Cohort 4 | EXPERIMENTAL | GSK961081 300mcg or Placebo |
| Name | Type | Description |
|---|---|---|
| GSK961081 15mcg SD | DRUG | Single dose delivered via solution for nebulisation |
| GSK961081 3mcg SD | DRUG | single dose delivered via nebulsier |
| GSK961081 50mcg SD | DRUG | single dose delivered via solution for nebulisation |
| Placebo SD | DRUG | single dose via nebuliser |
| GSK961081 100mcg SD | DRUG | single dose delivered via solution for nebulisation |
| GSK961081 200mcg SD | DRUG | single dose via nebuliser |
| GSK961081 300mcg SD | DRUG | single dose via nebuliser |
| GSK961081 100mcg RD | DRUG | repeat dose via nebuliser |
| GSK961081 300mcg RD | DRUG | repeat dose vai nebuliser |
| Placebo RD | DRUG | repeat dose via nebuliser |
Inclusion Criteria: * Healthy adult males aged between 18 and 50 years. * Body mass index within the range 18.5-29.9 kilograms/meter2 (kg/m2). * Forced Expiratory Volume in 1 second (FEV1) \<80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \<0.7 * Response to Salbutamol defined as: an in...
GSK961081 SD is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended to address respiratory conditions, specifically chronic obstructive pulmonary disease.
GSK961081 SD is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company is conducting clinical research on this investigational compound for the treatment of chronic obstructive pulmonary disease.
GSK961081 SD is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for chronic obstructive pulmonary disease.
GSK961081 SD has one completed clinical trial registered as NCT00887406, titled 'Study of GSK961081 in Healthy Volunteer Subjects.' This Phase 1 study enrolled 46 healthy male volunteers in the United Kingdom and evaluated the drug for chronic obstructive pulmonary disease.
GSK961081 SD is a formulation of the investigational compound GSK961081. The 'SD' designation likely refers to a specific dosage form or salt form of the drug. Both names refer to the same active pharmaceutical ingredient being developed for chronic obstructive pulmonary disease.