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GSK961081 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| All subjects | EXPERIMENTAL | Eligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days. |
| Sequence 1 | EXPERIMENTAL | In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. |
| Sequence 2 | EXPERIMENTAL | In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. |
| Sequence 3 | EXPERIMENTAL | In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4. |
| Sequence 4 | EXPERIMENTAL | In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. |
| Sequence 5 | EXPERIMENTAL | In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4. |
| Sequence 6 | EXPERIMENTAL | In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4. |
| Sequence 7 | EXPERIMENTAL | In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4. |
| Sequence 8 | EXPERIMENTAL | In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4. |
| Name | Type | Description |
|---|---|---|
| GSK961081 | DRUG | GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning. |
| GSK961081 matching placebo | DRUG | GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning. |
| Propranolol | DRUG | Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water. |
| Propranolol matching placebo | DRUG | Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water. |
Inclusion Criteria: * Healthy adult males aged between 18 and 50 years. * Body mass index within the range 19-29.9 kg/m2. * FEV1 ≥ 80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio ≥ 0.7 * Signed and dated written informed consent is obtained from the subject * The subject is able to unde...
GSK961081 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is a respiratory therapeutic that has been studied in early-stage clinical trials. As of the available data, GSK961081 is in Phase 1 development and has not been approved for any use.
GSK961081 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 drug for chronic obstructive pulmonary disease.
GSK961081 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The available data shows two completed Phase 1 trials, and no active trials are currently listed for this compound.
GSK961081 has two completed Phase 1 clinical trials. The first, NCT00550225, studied a succinate salt version of the drug in 18 healthy male volunteers in the United Kingdom. The second, NCT00687700, investigated the pharmacology of a dual pharmacophore in 23 healthy male volunteers, also in the United Kingdom.
GSK961081 is described as a dual pharmacophore, meaning it combines two active components in a single molecule. However, the specific molecular target or mechanism of action has not been disclosed in the available clinical trial information. The drug is being studied for its effects in chronic obstructive pulmonary disease.