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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01696604 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects | PHASE1 | COMPLETED | 17 | — | — | Sep 26, 2012 | May 3, 2013 | Jun 7, 2017 | 1 | United States |
Safety and tolerability parameters will include recording of AEs, throughout the study.
Safety and tolerability parameters will include recording of AEs, throughout the study.
Safety and tolerability parameter will include the ECG readings at Baseline and at end of the study.
Safety and tolerability parameter will include the ECG readings at Baseline and at end of the study.
Safety and tolerability parameters will include blood pressure readings at Baseline and at end of the study.
Safety and tolerability parameters will include blood pressure readings at Baseline and at end of the study.
Safety and tolerability parameters will include heart rate at Baseline and at end of the study.
Safety and tolerability parameters will include heart rate at Baseline and at end of the study.
Safety and tolerability parameters will include cardiac telemetry recording at Baseline and at end of the study.
Safety and tolerability parameters will include laboratory values at Baseline and at end of the study.
Safety and tolerability parameters will include laboratory values at Baseline and at end of the study.
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort 1-GSK2849466 | EXPERIMENTAL | The subjects will receive single planned dose of GSK284946 in ascending order (0.01, 0.03, 0.1, and 0.3 mg) in ratio of 3:1.with placebo within each of 4 treatment periods. The dose will not be allowed to exceed 30 mg over a 24-hour period. |
| Part A: Cohort 1-Placebo | EXPERIMENTAL | The subjects will receive single dose of matching placebo in one of the 4 treatment periods. |
| Part A: Cohort 2-GSK2849466 | EXPERIMENTAL | The subjects will receive single planned dose of GSK284946 in ascending order (0.3, 1, 3, and 10 mg) in ratio of 3:1.with placebo within each of 4 treatment periods. The dose will not be allowed to exceed 30 mg over a 24-hour period in one of the 4 treatment periods. |
| Part A: Cohort 2-Placebo | EXPERIMENTAL | The subjects will receive single dose of matching placebo in one of the 4 treatment periods. |
| Part B: Cohort 3-GSK2849466 (Repeat dose 1) | EXPERIMENTAL | The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo. |
| Part B: Cohort 3-Placebo (Repeat dose 1) | EXPERIMENTAL | The subjects will receive repeat dose of matching placebo. |
| Part B: Cohort 4-GSK2849466 (Repeat dose 2) | EXPERIMENTAL | The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo. In Cohort 4 subjects will be dosed in the fasted state on Days 1 and 14 and in the fed state on Day 7. |
| Part B: Cohort 4-Placebo (Repeat dose 2) | EXPERIMENTAL | The subjects will receive repeat doses of matching placebo. |
| Part B: Cohort 5-GSK2849466 (Repeat dose 3) | EXPERIMENTAL | The selection of appropriate doses for Part B will be performed upon consideration of available safety and tolerability and PK data from Part A and/or any preceding repeat dose cohorts. The subjects will receive GSK2849466 in ratio of 3:1.with placebo |
| Part B: Cohort 5-Placebo (Repeat dose 3) | EXPERIMENTAL | The subjects will receive repeat doses of matching placebo. |
| Name | Type | Description |
|---|---|---|
| GSK2849466 | DRUG | GSK2849466 will be available as capsules of dose strengths 0.01, 0.1, 1.0, and 2.5 mg. |
| Placebo | DRUG | Matching placebo capsules will be available. |
Inclusion Criteria: * Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form. * Body weight \>=50 kilogram (kg) and Body Mass Index (BMI) within the range 19 - 32 kg/meter (m)\^2 (inclusive), where BMI = (weight in kg)/(height in meters)\^2. * Healthy as ...