Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK1605786 capsule
GSK1605786 · 3 trials · 1 indication
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...
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GSK1605786 is an investigational small molecule developed by GSK plc for Crohn's disease, a gastrointestinal inflammatory condition. It has been studied in Phase 1 clinical trials, primarily in healthy volunteers, to evaluate its pharmacokinetics and drug interaction profile. It is not approved for any indication.
GSK1605786 is being investigated for Crohn's disease, a chronic inflammatory bowel condition. All three completed trials listed it under Crohn's disease as the condition, though the studies enrolled healthy volunteers rather than patients. No efficacy in Crohn's disease has been established, and the drug remains investigational.
GSK1605786 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all three Phase 1 trials of the compound, conducted in China, Australia, and the United States.
GSK1605786 is in Phase 1 development. All three of its clinical trials were Phase 1 studies, and all three are completed with no active trials ongoing. The compound has not been approved by the FDA or any other regulatory agency and remains investigational.
GSK1605786 has been studied in three completed Phase 1 trials: NCT01827631, a single and repeat dose pharmacokinetic study in healthy Chinese subjects; NCT01611805, a Japanese Phase 1 study conducted in Australia; and NCT01489943, which examined effects on hepatic cytochrome P450 and BCRP and OATP1B1 transport. Total enrollment across these trials was 75 participants.