Trial · NCT03568942
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Hours* nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time of Occurrence of Cmax (Tmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Hours | MEDIAN |
| PRIMARY | Apparent Steady State Clearance (CLss/F) of Gepotidacin | Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed. | Liters per hour | GEOMETRIC_MEAN |
| PRIMARY | Accumulation Ratio (Ro) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | PK Parameter Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | mg | GEOMETRIC_MEAN |
| SECONDARY | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | mg | GEOMETRIC_MEAN |
| SECONDARY | Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Percentage of dose | GEOMETRIC_MEAN |
| SECONDARY | Renal Clearance (CLr) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Liters per hour | GEOMETRIC_MEAN |
| SECONDARY | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs) | Up to Day 31 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Millimeters of mercury | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in Body Temperature | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Degree Celsius | MEAN |
| SECONDARY | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | Baseline; Day 1: 2 hours; Day 4: pre-dose and 2 hours | Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Millisecond | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | 10^9 cells per liter | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hemoglobin | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Grams per liter | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Hematocrit | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Percentage of red blood cells in blood | MEAN |
| SECONDARY | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Picogram | 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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GET https://conductscience.org/api/trials/v1/NCT03568942/outcomes