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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00387413 | A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers | PHASE1 | COMPLETED | 40 | — | — | Oct 2, 2006 | May 31, 2007 | Aug 7, 2017 | 1 | United Kingdom |
| 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...