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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01387217 | GSK2018682 FTIH in Healthy Volunteers | PHASE1 | COMPLETED | 27 | — | — | May 21, 2010 | Dec 20, 2010 | Jun 9, 2017 | 2 | Australia |
Adverse event and safety lab monitoring
12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682. |
| Part B | EXPERIMENTAL | Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions. |
| Name | Type | Description |
|---|---|---|
| GSK2018682 | DRUG | GSK2018682 |
| Placebo | DRUG | Matched Placebo |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters significantly outside the re...