Trial · NCT02243306
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Hour into nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 | PK Population | Hour into nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites | Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14 | PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Nanograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs) | Up to Day 24 | All subjects Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Millimoles per liter | MEAN |
| SECONDARY | Change From Baseline in Albumin and Protein Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Gram per liter (g/L) | MEAN |
| SECONDARY | Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Micromoles per liter | MEAN |
| SECONDARY | Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | International unit per liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels | Baseline and Day 3, 7, 11, 14, 17 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | IU/L | MEAN |
| SECONDARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | 10^9 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Erythrocyte and Reticulocyte Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | 10^12 cells/liter | MEAN |
| SECONDARY | Change From Baseline in Hematocrit Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Proportion of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin Levels | Baseline and Day 3, 7, 11, 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | g/L | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC) | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | g/L | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscular Volume (MCV) | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Femtoliter | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels | Baseline and Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Picograms | MEAN |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 17 | All Subjects Population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 17 and Day 24 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Millimeters of mercury | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate | Baseline, Day 17 and Day 24 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in Body Temperature | Baseline, Day 17 and Day 24 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles). | Degree celsius | MEAN |
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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