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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01827631 | Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects | PHASE1 | COMPLETED | 21 | — | — | May 27, 2013 | Jun 25, 2013 | Jun 7, 2017 | 1 | China |
| NCT01489943 | A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects | PHASE1 | COMPLETED | 24 | — | — | Sep 19, 2011 | Nov 10, 2011 | Jul 25, 2017 | 1 | United States |
| NCT01611805 | Japanese Phase I of GSK1605786 | PHASE1 | COMPLETED | 30 | — | — | Jul 22, 2010 | Oct 6, 2010 | Jun 14, 2017 | 1 | Australia |
maximum concentration after single dose and repeat dose
area under the concentration time curve during steady state
Midazolam AUC(0-infinity) following oral administration of midazolam alone (Day 1) and in combination with GSK1605786 (Day 11).Pioglitazone AUC(0-infinity) following oral administration of pioglitazone alone (Day 2) and in combination with GSK1605786 (Day 12).Omeprazole and 5-hydroxyomeprazole AUC(0-infinity) following oral administration of omeprazole alone (Day 3) and in combination with GSK1605786 (Day 13).
Rosuvastatin AUC(0-infinity) following oral administration of rosuvastatin alone (Day 4) and in combination with GSK1605786 (Day 14).
| Arm | Type | Description |
|---|---|---|
| GSK1605786 500 mg once daily | EXPERIMENTAL | GSK1605786 500 mg is given once daily in the morning |
| GSK1605786 500 mg twice daily | EXPERIMENTAL | GSK1605786 500 mg is given twice daily in the morning and in the evening |
| All subjects receiving treatment | EXPERIMENTAL | During the treatment subjects will receive Midazolam 3 mg on Day 1, Pioglitazone 15 mg on Day 2, Omeprazole 40 mg on Day 3, Rosuvastatin 10 mg on Day 4, GSK1605786 500 mg twice daily (BID) from Day 5 to 10, GSK1605786 500 mg BID + Midazolam 3 mg on Day 11, GSK1605786 500 mg BID + Pioglitazone 15 mg on Day 12, GSK1605786 500 mg BID + Omeprazole 40 mg on Day 12, GSK1605786 500 mg BID + Rosuvastatin 10 mg on Day 14 as single sequence. |
| GSK1605786 250mg | EXPERIMENTAL | Opaque Swedish orange body and cap. |
| Placebo | PLACEBO_COMPARATOR | Opaque Swedish orange body and cap. |
| GSK1605786 500mg | EXPERIMENTAL | Opaque Swedish orange body and cap. |
| GSK1605786 1000mg | EXPERIMENTAL | Opaque Swedish orange body and cap. |
| GSK1605786 500mg in fed | EXPERIMENTAL | Opaque Swedish orange body and cap. |
| Name | Type | Description |
|---|---|---|
| GSK1605786 capsule | DRUG | Swedish Orange, size 0, hard gelatine capsules |
| GSK1605786 500 mg | DRUG | Subjects will receive 500 milligram (mg) (2 doses of 250 mg) GSK1605786 hard gelatin capsules twice daily orally on Days 5 to 14. GSK1605786 will be administered with 240 milliliter (mL) of water. |
| Midazolam 3 mg | DRUG | Subjects will receive 3 mg oral syrup of Midazolam once daily on Day 1 and Day 11. Midazolam will be administered with 240 mL of water. |
| Pioglitazone 15 mg | DRUG | Subjects will receive 15 mg tablet of pioglitazone orally once daily on Day 2 and Day 12. Pioglitazone will be administered with 240 mL of water. |
| Omeprazole 40 mg | DRUG | Subjects will receive 40 mg hard gelatin capsules of Omeprazole once daily on Days 3 and 13. Omeprazole will be administered with 240 mL of water. |
| Rosuvastatin 10 mg | DRUG | Subjects will receive 10 mg tablet of Rosuvastatin orally once daily on Days 4 and 14. Rosuvastatin will be administered with 240 mL of water. |
| GSK1605786 | DRUG | Opaque Swedish orange body and cap. |
| GSK1605786 Placebo | DRUG | Opaque Swedish orange body and cap. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG * Male or female between 18 and 45 years of age * Body weight 50 kg (110lbs) for men and women, and body ma...