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Also known as Duloxetine
GSK189254 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A1 | EXPERIMENTAL | In treatment Arm A1 Period 1 subject will receive 50 mcg GSK189254 plus Duloxetine Placebo in Week 1, in Week 2 subject will receive 100 mcg GSK189254 plus Duloxetine Placebo and in Week 3 subject will receive GSK189254 Placebo plus Duloxetine Placebo. In treatment Arm A1 Period 2 subject will receive GSK189254 Placebo plus Duloxetine Placebo for all 3 Weeks. There will be a washout of approximately one week between periods 1 and 2. |
| Treatment Arm A2 | EXPERIMENTAL | In treatment Arm A2 Period 1 subject will receive GSK189254 Placebo plus Duloxetine Placebo for all 3 Weeks. In treatment Arm A2 Period 2 subject will receive 50 mcg GSK189254 plus Duloxetine Placebo in Week 1, in Week 2 subject will receive 100 mcg GSK189254 plus Duloxetine Placebo and in Week 3 subject will receive GSK189254 Placebo plus Duloxetine Placebo. There will be a washout of approximately one week between periods 1 and 2. |
| Treatment Arm B1 | EXPERIMENTAL | In treatment Arm B1 Period 1 subject will receive 30 milligram (mg) Duloxetine plus GSK189254 Placebo in Week 1, in Week 2 60 mg Duloxetine plus GSK189254 Placebo and in Week 3 30 mg Duloxetine plus GSK189254 Placebo. In treatment Arm B1 Period 2 subject will receive GSK189254 Placebo plus Duloxetine Placebo for all 3 Weeks. There will be a washout of approximately one week between periods 1 and 2. |
| Treatment Arm B2 | EXPERIMENTAL | In treatment Arm B2 Period 1 subject will receive GSK189254 Placebo plus Duloxetine Placebo for all 3 Weeks. In treatment Arm B2 Period 2 subject will receive 30 milligram (mg) Duloxetine plus GSK189254 Placebo in Week 1, in Week 2 60 mg Duloxetine plus GSK189254 Placebo and in Week 3 30 mg Duloxetine plus GSK189254 Placebo. There will be a washout of approximately one week between periods 1 and 2. |
| Name | Type | Description |
|---|---|---|
| Duloxetine | DRUG | Subjects will be receive hard gelatin capsules of Duloxetine at 30mg once daily for one week and 60mg once daily for the second week in Treatment Arm B. |
| GSK189254 | DRUG | Subjects will receive film coated tablet of GSK189254 at 50 mcg once daily for a one week and 100 mcg once daily for the second week in Treatment Arm A. |
| GSK189254 Placebo | DRUG | Subjects will receive Placebo matching GSK189254 for 3 weeks in each period. |
| Duloxetine Placebo | DRUG | Subjects will receive Placebo matching Duloxetine for 3 weeks in each period. |
Inclusion Criteria: * He/she is a healthy subject. * Women of child bearing potential must have a negative pregnancy test at screening and have undergone, or confirm regular use of one of the following: Female sterilisation Sterilisation of male partner Practising a clinically accepted method of c...
GSK189254 is an investigational small molecule being studied for hyperalgesia, a condition of heightened pain sensitivity. It was evaluated in a Phase 1 trial that used an electrical hyperalgesia model in healthy volunteers. It is not an approved medicine and remains in clinical development for pain-related research.
GSK189254 targets HRH3, the histamine H3 receptor, and acts as an antagonist at that receptor. By blocking HRH3, the compound is designed to modulate histamine signaling relevant to pain processing. This mechanism underlies its investigation in hyperalgesia within the pain therapeutic area.
GSK189254 is developed by GSK plc, the British pharmaceutical company listed under the ticker GSK. GSK sponsored the clinical research on the compound, including the Phase 1 study conducted in the United Kingdom. The asset sits within GSK's pain research portfolio.
GSK189254 is in Phase 1 clinical development. Its single recorded trial, NCT00387413, was a completed Phase 1 study. The drug is investigational and has not been approved for any indication. No active trials are currently listed for this asset.
GSK189254 has been studied in one clinical trial, NCT00387413, titled A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers. The Phase 1 trial enrolled 40 healthy adult participants in the United Kingdom, was randomized and controlled, and has completed.