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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00945503 | Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time. | PHASE1 | COMPLETED | 12 | — | — | May 19, 2008 | Dec 22, 2008 | Jul 18, 2017 | 1 | Spain |
| NCT00527020 | First Time in Human Study With GSK1018921 | PHASE1 | COMPLETED | 27 | — | — | Aug 10, 2007 | Jul 12, 2008 | Aug 4, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| GSK1018921 | EXPERIMENTAL | All subjects will received a dose of GSK1018921 and will peforme three PET scans using the ligand \[11C\]GSK931145, but in order to obtain adequate sampling of the exposure-time-occupancy curves, a range of doses will be evaluated, and the timing of the post-dose scans will differ between subjects. |
| Part A: Subjects receiving treatment in cohort A | EXPERIMENTAL | Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days. |
| Part A: Subjects receiving treatment in cohort B | EXPERIMENTAL | Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days. |
| Part A: Subjects receiving treatment in cohort C | EXPERIMENTAL | Eligible subjects will be randomized to receive GSK101892 and placebo. Subjects will receive escalated doses of GSK101892 with a starting dose of 0.5 milligrams. Each subject will receive no more than 4 doses of GSK1018921 in a maximum of 5 dosing sessions. Within each cohort, each session will be separated by a washout period of at least 7 days. |
| Part B: Subjects in 5 period crossover period | EXPERIMENTAL | Eligible subjects (first 14 subjects) will be randomized to one of the following 14 sequences as a 5 period crossover with sequences; LMNOQ, MNOLQ, NOLMQ, OLMNQ, ONMLQ, NMLOQ, MLONQ, LONMQ, LNMOQ, NMOLQM MOLNQ, OLNMQ, OMNLQ and MNLOQ) (L= 80 milligrams GSK1018921 given in fasted state, M= 200 milligrams GSK1018921 given in fasted state, N= nicotine lozenge, O= placebo and Q= 80 milligrams GSK1018921 in fed state). |
| Part B: Subjects in 4 period crossover period | EXPERIMENTAL | Eligible subjects (last 7 subjects) will be randomized to one of the following 7 sequences as a 4 period crossover with sequences; NLOM, LOMN, OLNM, LNMO, NMOL, MOLN, and MNLO. |
| Name | Type | Description |
|---|---|---|
| GSK1018921 | DRUG | GSK1018921 is a GT1 recepor antagonist |
| Nicotine Lozenges | DRUG | Nicotine Lozenges will be supplied as 4 milligrams lozenges. |
| Placebo | DRUG | Placebo tablets will be given to the subjects. |
* Inclusion criteria: * Healthy male subjects * Age: 18-55 years * No history of physical, neurological or mental illness * Exclusion criteria * History of claustrophobia or inability to lie still in the PET camera for at least 2 hours * Cardiac pacemakers or metal implants in the body t...