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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551811 | Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone | PHASE1 | COMPLETED | 23 | — | — | Oct 8, 2007 | Jul 22, 2008 | Aug 7, 2017 | 1 | Germany |
| NCT00504439 | A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects | PHASE1 | COMPLETED | 36 | — | — | Jun 4, 2007 | Sep 6, 2007 | Aug 3, 2017 | 1 | United Kingdom |
| 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...