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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00703547 | A First Time in Human Study of GSK586529 in Healthy Volunteers | PHASE1 | COMPLETED | 21 | — | — | Jan 28, 2008 | Apr 11, 2008 | Aug 22, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving treatment in cohort 1 | EXPERIMENTAL | Subjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5). |
| Subjects receiving treatment in cohort 2 | EXPERIMENTAL | Subjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6) |
| Name | Type | Description |
|---|---|---|
| GSK586529 capsules | DRUG | GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams. |
| GSK586529 tablets | DRUG | GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams. |
| Placebo | DRUG | Placebo tablets and capsules will be provided to subjects. |
Inclusion Criteria: * Healthy males aged 18-45 years, inclusive. * Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests. *...