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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02801981 | Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers | PHASE1 | COMPLETED | 16 | — | — | Jun 1, 2016 | Aug 1, 2016 | Nov 9, 2016 | 1 | Japan |
Systolic and diastolic blood pressure will be measured on Day -1, post dose 2 hours (hrs), 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Heart rate will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Body temperature will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Fecal occult blood testing will be conducted on Screening (2 samples during Screening period) and each dosing period (anytime from dosing to next dose).
Electrocardiogram will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
| Arm | Type | Description |
|---|---|---|
| Sequence 1: GSK2230672 10mg, 30mg, 90mg, and Placebo | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and placebo in period 4. |
| Sequence 2:GSK2230672 10mg, 30mg, Placebo, and GSK2230672 90mg | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, GSK2230672 30 mg in Period 2, placebo in period 3, and GSK2230672 90 mg in period 4. |
| Sequence 3:GSK2230672 10mg, Placebo, GSK2230672 90mg and 180mg | EXPERIMENTAL | Subjects will receive GSK2230672 10 mg in period 1, placebo in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4. |
| Sequence 4: Placebo, GSK2230672 30mg, 90mg and 180mg | EXPERIMENTAL | Subjects will receive placebo in period 1, GSK2230672 30 mg in Period 2, GSK2230672 90 mg in Period 3 and GSK2230672 180 mg in period 4. |
| Name | Type | Description |
|---|---|---|
| GSK2230672 | DRUG | It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672. |
| Placebo | DRUG | It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672 |
Inclusion Criteria: * Japanese male aged between 20 and 64 years of age inclusive, at the time of signing the informed consent * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests ...