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SB-656933-AAA · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving treatment sequence 1 | EXPERIMENTAL | Eligible subjects will receive single doses of placebo in period 1, SB-656933-AAA with a dose of 50 milligrams in period 2 and 150 milligrams in period 3. |
| Subjects receiving treatment sequence 2 | EXPERIMENTAL | Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, placebo in period 2 and SB-656933-AAA 150 milligrams in period 3. |
| Subjects receiving treatment sequence 3 | EXPERIMENTAL | Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, 150 milligrams in period 2 and placebo in period 3. |
| Cohort 1 | EXPERIMENTAL | Subjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days. |
| Cohort 2 | EXPERIMENTAL | Subjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction. |
| Cohort 3 | EXPERIMENTAL | Subjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing. |
| Name | Type | Description |
|---|---|---|
| SB-656933-AAA | DRUG | SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally. |
| Placebo | DRUG | Placebo tablets will be intended to be administered orally. |
| Matching placebo | DRUG | SB-656933-AAA matching placebo tablets will be administered orally. |
| Simvastatin | DRUG | Simvastatin will be provided as a 40 mg tablet. |
Inclusion Criteria: * Healthy subjects between 18-50 years. * Females should be of non-child bearing potential. * Non-smoking for at least 12 months. * Normal lung function. * Subjects should be able to produce acceptable sputum samples. Exclusion Criteria: * Any serious medical condition. * Hepa...
SB-656933-AAA is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is currently in Phase 1 clinical development, meaning it has not been approved and is still being studied for safety and tolerability in humans.
SB-656933-AAA is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for chronic obstructive pulmonary disease.
SB-656933-AAA is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed two Phase 1 trials. Both trials were completed, with no active trials currently ongoing.
SB-656933-AAA has completed two Phase 1 clinical trials. NCT00504439 evaluated safety and tolerability after repeated doses in healthy adult subjects in the United Kingdom, enrolling 36 participants. NCT00551811 evaluated effects after a single dose in subjects who inhaled ozone in Germany, enrolling 23 participants.
No alternative names for SB-656933-AAA have been reported. It is known only by this identifier in clinical trials. The drug is being studied under this name in Phase 1 trials for chronic obstructive pulmonary disease.