Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
GSK1605786 is an investigational small molecule being studied for Crohn's Disease. It is in Phase 1 clinical development, with all three completed trials enrolling healthy volunteers to assess the drug's effects, pharmacokinetics, and safety. GSK1605786 is not approved and remains under clinical investigation.
GSK1605786 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects across multiple regions.
GSK1605786 is in Phase 1 clinical development. All three trials for this drug have been completed, with a total enrollment of 75 participants. The studies were randomized, double-blind, and controlled, focusing on healthy volunteers to evaluate the drug's effects and pharmacokinetic profile.
GSK1605786 has three completed Phase 1 trials: NCT01489943, a US study on hepatic cytochrome P450 and transporter effects in 24 healthy adults; NCT01611805, a Japanese Phase I study in 30 healthy males in Australia; and NCT01827631, a pharmacokinetic study in 21 healthy Chinese subjects.
GSK1605786 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for Crohn's Disease. All completed studies have involved healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory submission.
No alternative names for GSK1605786 have been reported. The drug is identified solely by its code name GSK1605786 in all clinical trial records, and no other brand or generic names are associated with it in the available data.