Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2849466 · 1 trial · 1 indication
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 ...
GSK2849466 is an investigational small molecule developed by GSK plc for cachexia, a wasting condition involving loss of muscle and body weight. It has been studied in a Phase 1 clinical trial in healthy male volunteers. It is not an approved medicine and remains in early clinical development.
GSK2849466 is being developed for cachexia, a condition characterized by progressive loss of muscle and body weight. Its only recorded clinical trial enrolled healthy male volunteers rather than patients with cachexia, so the study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics rather than treatment benefit in patients.
GSK2849466 targets the androgen receptor, or AR, and is classified as an AR modulator. The androgen receptor is a nuclear hormone receptor that regulates gene expression in response to androgens. GSK2849466 is a small molecule that modulates this receptor, and it is being explored in the oncology therapeutic area.
GSK2849466 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 study of the compound conducted in the United States. GSK plc is the sole developer named for this asset.
GSK2849466 is in Phase 1 development. Its single recorded trial, NCT01696604, was a Phase 1 study that has been completed. The compound is investigational and has not been approved for any indication.
GSK2849466 has been evaluated in one clinical trial, NCT01696604, titled A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects. The Phase 1 trial enrolled 17 healthy male volunteers in the United States, was randomized, double blind, and controlled, and is now completed.