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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01090440 | Pharmacokinetics, Effect of Food, Safety and Tolerability of a New Tablet Formulation of GSK1144814 in Healthy Subjects | PHASE1 | COMPLETED | 16 | — | — | Sep 1, 2009 | Oct 9, 2009 | Jun 22, 2017 | 1 | Australia |
| NCT01209039 | A Repeat Dose Positron Emission Tomography Study With GSK1144814 | PHASE1 | COMPLETED | 41 | — | — | Jul 1, 2009 | Oct 25, 2009 | Jun 20, 2017 | 2 | United Kingdom |
| NCT01381419 | First Time in Human Study (FTIH) With Positron Emission Tomography (PET) | PHASE1 | COMPLETED | 21 | — | — | Oct 20, 2008 | Apr 1, 2009 | Jul 7, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Three-way cross- over | EXPERIMENTAL | Three regimens will be administered in this study: A: GSK1144814 Tablet (100mg) Fasted State; B: GSK1144814 Tablet (200mg) Fasted State and C: GSK 1144814 Tablet (100mg) Fed State (FDA high fat breakfast). |
| Part A, cohort 1 and 2 | EXPERIMENTAL | Part A, Cohorts 1 and 2, will investigate escalating multiple daily doses of GSK1144814 in 19 subjects |
| Part A, cohort 3 | EXPERIMENTAL | Cohort 3 will investigate safety, tolerability and PK of a dose of GSK1144814 over a repeat treatment period of 28 days in 18 subjects and a potential drug drug interaction between GSK1144814 and the CYP3A4 sensitive substrate midazolam (in 15 subjects). |
| Part B | EXPERIMENTAL | Part B will assess NK1 receptor occupancy following repeated administration of GSK1144814 given once daily until steady state is obtained |
| Part A, Cohort 1 | EXPERIMENTAL | In Cohort 1, four subjects (two on active and two on placebo for first dose, and then three on active and one on placebo for subsequent doses) will be included. Subjects will be dosed at least 30 minutes apart over the dosing day and only doses administered where the predicted plasma concentration will remain below those corresponding to the MABEL. |
| Part A, cohort 2 | EXPERIMENTAL | In Cohort 2, 10 subjects will be included (8 active : 2 placebo). Dosing will start once the previous cohort (Cohort 1) has completed the Treatment Phase. For Cohort 2 and any subsequent cohorts, dosing will take place on two different days when a new dose is administered such that no more than one subject receives the agreed ascending dose on the first dosing day. Doses may be split in up to three divided doses given 2 to 3 hours apart. Dosing for the first four sessions in each cohort will be staggered over 2 days. On the first day of each dosing session, only one subject will receive the highest dose for that dosing session and at least one subject each will receive placebo. The remaining subjects in the cohort will be dosed on the second day according to the randomisation plan. |
| Name | Type | Description |
|---|---|---|
| GSK1144814 | DRUG | This study is an open label, randomised, three-way cross-over study to evaluate the pharmacokinetics, effect of food, safety and tolerability of a new tablet formulation of GSK1144814 in healthy male and female (non-child bearing potential) subjects. Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast. |
Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameters significantly outside the refe...