Approval Probability
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Adjusted LOA
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GSK2586881 · 1 trial · 1 indication
PVR is the resistance generated by pulmonary circulation. Pulmonary arterial catheters were placed in participants and PVR values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.
CO is the amount of blood pumped by the heart per minute. Pulmonary arterial catheters were placed in participants and CO values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.
The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Pulmonary arterial catheters were placed in participants and mPAP values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.
| Arm | Type | Description |
|---|---|---|
| GSK2586881 - 0.1 mg/kg | EXPERIMENTAL | Eligible subjects will receive a single dose of 0.1 mg/kg GSK2586881. Dose escalation up to maximum dose of 0.8 mg/kg will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. |
| GSK2586881 - 0.2 mg/kg | EXPERIMENTAL | Eligible subjects will receive a single dose 0.2 mg/kg of GSK2586881 IV infusion. Dose escalation up to maximum dose of 0.8 mg/kg will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. |
| GSK2586881 - 0.4 mg/kg | EXPERIMENTAL | Eligible subjects will receive a single dose of 0.4 mg/kg of GSK2586881 IV infusion. Dose escalation up to maximum dose of 0.8 mg/kg will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. |
| GSK2586881 - 0.8 mg/kg | EXPERIMENTAL | Eligible subjects will receive single dose of 0.8 mg/kg of GSK2586881 IV infusion. Dose escalation will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. |
| Name | Type | Description |
|---|---|---|
| GSK2586881 | DRUG | GSK2586881 is a clear colorless liquid for IV infusion over 3- 5 minutes and will be administered a maximum dose of 0.8 mg/kg. |
Inclusion Criteria * Subjects must be between 18-75 years of age (inclusive), at the time of signing the informed consent. * Documented diagnosis of PAH, defined as mPAP \> 25 millimeter of mercury (mmHg) and pulmonary wedge pressure (PWP) \<= 15. * Idiopathic PAH (IPAH), Hereditary PAH (HPAH), or ...
GSK2586881 is an investigational small molecule being studied for acute lung injury and pulmonary arterial hypertension. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being developed by GSK plc.
GSK2586881 is a small molecule being studied in respiratory conditions. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its effects in patients with acute lung injury and pulmonary arterial hypertension.
GSK2586881 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in respiratory conditions.
GSK2586881 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in acute lung injury and one in pulmonary arterial hypertension. The drug is investigational and has not received regulatory approval.
GSK2586881 has been studied in two completed Phase 2 trials. NCT01597635 evaluated the drug in 44 patients with acute lung injury in the United States and Canada. NCT03177603 was a dose-escalation study in 23 patients with pulmonary arterial hypertension in the United States, Germany, and Spain.
GSK2586881 is the code name for this investigational compound. No alternative brand names have been reported in clinical trial records. The drug is being studied under this identifier in trials for acute lung injury and pulmonary arterial hypertension.