Trial · NCT03223337
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC (0-infinity) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Percentage of AUCex | MEAN |
| PRIMARY | Part 2: Percentage AUCex of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Percentage of AUCex | MEAN |
| PRIMARY | Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: AUC (0-t) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hour*nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 2: Cmax of GSK1278863 and Its Metabolites. | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hours | GEOMETRIC_MEAN |
| PRIMARY | Part 2: T1/2 of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hours | GEOMETRIC_MEAN |
| PRIMARY | Part 1: Time of Occurrence of Cmax (Tmax) of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population | Hours | MEDIAN |
| PRIMARY | Part 2: Tmax of GSK1278863 and Its Metabolites | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed. | Hours | MEDIAN |
| PRIMARY | Part 1: Unbound Concentration in Plasma of GSK1278863 and Its Metabolites | 3 hours, 12 hours and 24 hours post-dose | Pharmacokinetic Population | Nanograms per milliliter | MEAN |
| PRIMARY | Part 2: Unbound Concentration in Plasma of GSK1278863 and Its Metabolites | 3 hours, 12 hours and 24 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Nanograms per milliliter | MEAN |
| PRIMARY | Part 1: Unbound Fraction in Plasma of GSK1278863 and Its Metabolites | 3 hours, 12 hours and 24 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Percentage of unbound drug in plasma | MEAN |
| PRIMARY | Part 2: Unbound Fraction in Plasma of GSK1278863 and Its Metabolites | 3 hours, 12 hours and 24 hours post-dose | Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles). | Percentage of unbound drug in plasma | MEAN |
| SECONDARY | Part 1: Maximum Observed Erythropoietin Concentration (Cmax, EPO) Following Administration of GSK1278863 | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose | Pharmacodynamic Population | International units per liter | MEAN |
| SECONDARY | Part 2: Cmax, EPO Following Administration of GSK1278863 | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose | Pharmacodynamic Population | International units per liter | MEAN |
| SECONDARY | Part 1: Time of the Maximum Observed Erythropoietin Concentration (Tmax, EPO) Following Administration of GSK1278863 | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose | Pharmacodynamic Population | Hours | MEDIAN |
| SECONDARY | Part 2: Tmax, EPO Following Administration of GSK1278863 | Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose | Pharmacodynamic Population | Hours | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03223337/outcomes