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This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required. The objective of this study is to compare the pharmacokinetics of gepotidacin administered as a 750 milligram (mg) intravenous (IV) dose in normal healthy subjects compared with subjects with mild, moderate, and severe renal impairment, and with subjects with end stage renal disease (ESRD). This is a Phase I, nonrandomized, open-label, parallel-group, multi-center, multi-part study. In Part 1, up to 16 subjects with normal renal function will be matched to approximately 8 subjects with moderate renal impairment, and approximately 8 subjects with severe renal impairment and/or subjects with ESRD not on hemodialysis for a total of approximately 32 subjects. In Part 2 (optional), approximately 4 to 8 subjects with normal renal function (if enrolled), approximately 4 to 8 subjects with mild renal impairment, and approximately 4 to 8 subjects with ESRD on hemodialysis will be enrolled for a total of approximately 12 to 24 subjects. The duration from Screening to the Follow-up Visit will be approximately 44 days for Part 1 and approximately 50 days for Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Subjects with normal renal function (Group A) | Experimental | Subjects with normal renal function will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion. |
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| Part 1: subjects with moderate renal impairment (Group B) | Experimental | Subjects with moderate renal impairment will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion. |
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| Part 1: subjects with severe renal impairment (Group C) | Experimental | Subjects with severe renal impairment and subjects with ESRD not on hemodialysis will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion. |
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| Part 2: subjects with normal renal function (Group D) | Experimental | Subjects with normal renal function will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion. |
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| Part 2: subjects with mild renal impairment (Group E) | Experimental | Subjects with mild renal impairment will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gepotidacin | Drug | Gepotidacin after reconstitution is a clear, dark brown to dark brownish-yellow solution, free from visible particulate matter. Subjects will receive gepotidacin 750 mg single IV dose over 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) From Hour 0 to Infinity (AUC[0-inf]) of Gepotidacin for Part 1 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity . Blood samples were collected at the indicated time-points, during the study. The Pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. The PK Population consisted of all participant's, who received at least 1 dose of gepotidacin and had evaluable PK data. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| AUC (0-inf) of Gepotidacin for Part 2 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for gepotidacin. Blood samples were collected at the indicated time-points, during the study. | Pre-dose, 0.25 hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Maximum Observed Plasma Concentration (Cmax) of Gepotidacin for Part 1 | Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Cmax of Gepotidacin for Part 2 | Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific timepoints during the study. No formal analysis of group comparison was planned for dialysate PK parameters |
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Inclusion Criteria:
Nonreproductive potential defined as:
Reproductive potential and agrees to follow 1 of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential requirements from 30 days prior to the first dose until completion of the Follow-up Visit.
For subjects with indeterminate pregnancy test results or a persistently low human chorionic gonadotropin results, nonpregnancy status must be documented by other means (subjects with ESRD only).
Exclusion Criteria:
Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk, in the opinion of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33136 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32429000 | Background | Hossain M, Tiffany C, Raychaudhuri A, Nguyen D, Tai G, Alcorn H Jr, Preston RA, Marbury T, Dumont E. Pharmacokinetics of Gepotidacin in Renal Impairment. Clin Pharmacol Drug Dev. 2020 Jul;9(5):560-572. doi: 10.1002/cpdd.807. Epub 2020 May 19. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 43 participants were screened of which 8 were screen-failures and 32 were enrolled in the study and 3 participants were reserve participants and were no longer required in the study .
A 2-part study, conducted in participant's with varying degree of renal impairment (RI) which enrolled 32 participants, wherein, 24 participants were enrolled in Part 1 and 8 participants in Part 2. The study was conducted, at 3 centers in United States of America from 29 June 2016 to 20 June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal, Part 1 | The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated creatinine clearance (Clcr) >= 90 milliliter per minute), in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| FG001 | Moderate | The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| FG002 | Severe/ESRD Not on Hemodialysis, Part 1 | The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| FG003 | ESRD on Hemodialysis, Part 2 | The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (Up to 44 Days) |
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| Part 2 (Up to 50 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal, Part 1 | The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated Clcr >= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Time Curve (AUC) From Hour 0 to Infinity (AUC[0-inf]) of Gepotidacin for Part 1 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity . Blood samples were collected at the indicated time-points, during the study. The Pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. The PK Population consisted of all participant's, who received at least 1 dose of gepotidacin and had evaluable PK data. | PK Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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AEs and SAEs were collected from the start of study treatment upto 94 days
AEs and SAEs were collected in Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal, Part 1 | The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute per 1.73 meter^2 or estimated Clcr >= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2016 | Jun 14, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2016 | Jun 14, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C000612856 | gepotidacin |
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| Part 2: subjects with ESRD on hemodialysis (Group F) | Experimental | Subjects with ESRD on hemodialysis will receive a single dose of gepotidacin 750 mg administered as a 2 hour IV infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 mg administered as a 2 hour IV infusion starting within 2 hours after completion of the last hemodialysis session of the week (Period 2). |
|
| Total Amount Excreted in Urine (Ae Total), Part 1 |
Urine samples from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. No formal statistical analysis of group comparison was planned for urine PK parameters. |
| Pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
| Ae Total of Gepotidacin for Part 2 | Urine samples, from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. Urine samples were collected at pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters. | Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2 |
| Percentage of the Given Dose Excreted in Urine (fe%) of Gepotidacin for Part 1 | The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. | At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
| fe% of Gepotidacin for Part 2 | The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. No formal statistical analysis of group comparison was planned for urine PK parameters. Only those participants available at the specified time points were analyzed. | At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods |
| Renal Clearance (CLr) of Gepotidacin for Part 1 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). The renal clearance was calculated by Ae total divided by AUC from hour 0 to the last measurable plasma concentration AUC (0-t). Urine samples were collected at pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. No formal statistical analysis of group comparison was planned for urine PK parameters. | At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
| CLr of Gepotidacin for Part 2 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). Urine samples were collected at pre-dose (0.0), 0 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters. | At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods |
| AUC (t0-t1) of Gepotidacin for Part 2 | Partial area under the curve estimated from predialyzer samples collected from start of dialysis (t0) to end of dialysis (t1). Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm.. | Dialysate fluid were to be collected on Day 1 after dosing (Period 1 only) at pre-dose from 0 to 4 hours |
| Dialysis Clearance (CLD) of Gepotidacin for Part 2 | CLD measured the dialysis clearance of gepotidacin over the specified duration in the study and indicates how quickly gepotidacin is cleared out from blood or plasma. Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm. | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1 |
| Fraction (%) of the Dose Removed by Hemodialysis From 0 to 4 Hours After the Start of Hemodialysis (Frem%[0-4]) of Gepotidacin for Part 2 | Dialysate samples were collected at specified time points in the study. Frem is defined as the fraction (dose in percentage) removed by the process of hemodialysis from 0 to 4 hours after the start of hemodialysis (or to the end of dialysis if less than 4 hours) | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1 |
| Up to 16 Days |
| Number of Participants With Abnormal 12-lead ECG Readings for Part 2 | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific time points during the study. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates data was not available | Up to 23 Days |
| Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Baseline was defined as the latest pre-dose assessment. Change from Baseline, was defined as post Baseline values minus the values at Baseline. | Baseline and up to 16 Days |
| Change From Baseline in Vitals- SBP and DBP, Part 2 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Baseline and up to 23 Days |
| Change From Baseline in Vitals- Pulse Rate, Part 1 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment | Baseline and up to 16 Days |
| Change From Baseline in Vitals- Pulse Rate, Part 2 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Baseline and Up to 23 Days |
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) for Part 1 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. | Up to 16 Days |
| Number of Participants With Any AEs and Any SAEs for Part 2 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. | Up to 23 Days |
| Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 1 | The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported. | Up to 17 Days |
| Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 2 | The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported. | Up to 24 Days |
| Number of Participants With Abnormal Physical Examination Results for Part 1 | Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected. | Up to 16 Days |
| Number of Participants With Abnormal Physical Examination Results for Part 2 | Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected. | Up to 23 Days |
| AUC (0-t) of Gepotidacin for Part 1 | Blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| AUC (0-t) of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Systemic Clearance (CL) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf). | At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose during the single treatment period. |
| CL of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf). | At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in each of the two treatment periods |
| Terminal Elimination Rate Constant (lambda_z) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Lambda_z of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both |
| Terminal Phase Half-life (t1/2) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| t1/2 of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Time to Maximum Plasma Concentration (Tmax) of Gepotidacin for Part1 | Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Tmax of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Volume of Distribution at Steady State of Parent Drug (Vss) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Vss of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Volume of Distribution of the Terminal Phase (Vz) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
| Vz of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant. | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
| Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Normal | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function. | At Pre-dose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours |
| Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Moderate and Severe | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | at pre-dose (0.0), 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 36, and 36 to 48 hours post-dose during the single treatment period |
| Ae(t1-t2) of Gepotidacin for Part 2 | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function. NA indicates data is not available due to insufficient participants.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2 |
| Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 | Arem is defined as the total amount of drug removed using the hemodialysis method at different timepoints namely Arem (0-1), measured the amount of drug removed by hemodialysis from time 0 to 1 hour after the start of hemodialysis; Arem (1-2), measured the amount of drug removed by hemodialysis from time 1 to 2 hours after the start of hemodialysis; Arem(2-3) ), measured the amount of drug removed by hemodialysis from time 2 to 3 hour, Arem (3-4), measured the amount of drug removed by hemodialysis from hemodialysis from time 3 to 4 hours after the start of hemodialysis (or to the end of dialysis if <4 hours). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1Dialysate fluid were collected at 1, 2, 3, and 4 hours post-dose in Period 1 only |
| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Moderate, Part 1 |
The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| BG002 | Severe/ESRD Not on Hemodialysis, Part 1 | The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| BG003 | ESRD on Hemodialysis, Part 2 | The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2). |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Moderate, Part 1 | The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
| OG002 | Severe/ESRD Not on Hemodialysis, Part 1 | The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. |
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| Primary | AUC (0-inf) of Gepotidacin for Part 2 | AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for gepotidacin. Blood samples were collected at the indicated time-points, during the study. | PK Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose, 0.25 hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Gepotidacin for Part 1 | Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin. | PK Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Primary | Cmax of Gepotidacin for Part 2 | Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both. |
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| Primary | Total Amount Excreted in Urine (Ae Total), Part 1 | Urine samples from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. No formal statistical analysis of group comparison was planned for urine PK parameters. | PK Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram. | Pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
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| Primary | Ae Total of Gepotidacin for Part 2 | Urine samples, from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. Urine samples were collected at pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram | Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2 |
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| Primary | Percentage of the Given Dose Excreted in Urine (fe%) of Gepotidacin for Part 1 | The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of gepotidacin | At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
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| Primary | fe% of Gepotidacin for Part 2 | The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. No formal statistical analysis of group comparison was planned for urine PK parameters. Only those participants available at the specified time points were analyzed. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of gepotidacin | At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods |
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| Primary | Renal Clearance (CLr) of Gepotidacin for Part 1 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). The renal clearance was calculated by Ae total divided by AUC from hour 0 to the last measurable plasma concentration AUC (0-t). Urine samples were collected at pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. No formal statistical analysis of group comparison was planned for urine PK parameters. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period |
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| Primary | CLr of Gepotidacin for Part 2 | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). Urine samples were collected at pre-dose (0.0), 0 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods |
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| Primary | AUC (t0-t1) of Gepotidacin for Part 2 | Partial area under the curve estimated from predialyzer samples collected from start of dialysis (t0) to end of dialysis (t1). Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm.. | PK parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Dialysate fluid were to be collected on Day 1 after dosing (Period 1 only) at pre-dose from 0 to 4 hours |
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| Primary | Dialysis Clearance (CLD) of Gepotidacin for Part 2 | CLD measured the dialysis clearance of gepotidacin over the specified duration in the study and indicates how quickly gepotidacin is cleared out from blood or plasma. Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1 |
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| Primary | Fraction (%) of the Dose Removed by Hemodialysis From 0 to 4 Hours After the Start of Hemodialysis (Frem%[0-4]) of Gepotidacin for Part 2 | Dialysate samples were collected at specified time points in the study. Frem is defined as the fraction (dose in percentage) removed by the process of hemodialysis from 0 to 4 hours after the start of hemodialysis (or to the end of dialysis if less than 4 hours) | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of gepotidacin removed | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1 |
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| Secondary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific timepoints during the study. No formal analysis of group comparison was planned for dialysate PK parameters | The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. | Posted | Number | Participants | Up to 16 Days |
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| Secondary | Number of Participants With Abnormal 12-lead ECG Readings for Part 2 | Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific time points during the study. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates data was not available | Participants | Posted | Number | Participants | Up to 23 Days |
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| Secondary | Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Baseline was defined as the latest pre-dose assessment. Change from Baseline, was defined as post Baseline values minus the values at Baseline. | Safety Population | Posted | Mean | Standard Deviation | Milliliter of mercury | Baseline and up to 16 Days |
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| Secondary | Change From Baseline in Vitals- SBP and DBP, Part 2 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Safety Population | Posted | Mean | Standard Deviation | Milliliter of mercury | Baseline and up to 23 Days |
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| Secondary | Change From Baseline in Vitals- Pulse Rate, Part 1 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment | Safety Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and up to 16 Days |
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| Secondary | Change From Baseline in Vitals- Pulse Rate, Part 2 | Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Safety Population. | Posted | Mean | Standard Deviation | beats per minute | Baseline and Up to 23 Days |
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| Secondary | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) for Part 1 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. | Safety Population | Posted | Number | Participants | Up to 16 Days |
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| Secondary | Number of Participants With Any AEs and Any SAEs for Part 2 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. | Safety Population | Posted | Number | Participants | Up to 23 Days |
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| Secondary | Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 1 | The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported. | Safety Population | Posted | Number | Participants | Up to 17 Days |
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| Secondary | Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 2 | The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported. | Safety Population | Posted | Number | Participants | Up to 24 Days |
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| Secondary | Number of Participants With Abnormal Physical Examination Results for Part 1 | Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected. | Safety Population. This data was not collected. | Posted | Up to 16 Days |
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| Secondary | Number of Participants With Abnormal Physical Examination Results for Part 2 | Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected. | Safety Population: This data was not collected. | Posted | Up to 23 Days |
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| Secondary | AUC (0-t) of Gepotidacin for Part 1 | Blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | AUC (0-t) of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Secondary | Systemic Clearance (CL) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf). | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose during the single treatment period. |
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| Secondary | CL of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf). | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in each of the two treatment periods |
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| Secondary | Terminal Elimination Rate Constant (lambda_z) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | Lambda_z of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both |
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| Secondary | Terminal Phase Half-life (t1/2) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. | PK Parameter Population | Posted | Median | Full Range | hours | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | t1/2 of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. | Pharmacokinetic Parameter Population | Posted | Median | Full Range | hours | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of Gepotidacin for Part1 | Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | Pharmacokinetic Parameter Population | Posted | Mean | Full Range | hours | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | Tmax of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | PK Parameter Population | Posted | Median | Full Range | hours | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Secondary | Volume of Distribution at Steady State of Parent Drug (Vss) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | Vss of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Secondary | Volume of Distribution of the Terminal Phase (Vz) of Gepotidacin for Part 1 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose. |
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| Secondary | Vz of Gepotidacin for Part 2 | Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both. |
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| Secondary | Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Normal | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram | At Pre-dose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours |
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| Secondary | Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Moderate and Severe | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram | at pre-dose (0.0), 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 36, and 36 to 48 hours post-dose during the single treatment period |
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| Secondary | Ae(t1-t2) of Gepotidacin for Part 2 | Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function. NA indicates data is not available due to insufficient participants.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram | Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2 |
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| Secondary | Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 | Arem is defined as the total amount of drug removed using the hemodialysis method at different timepoints namely Arem (0-1), measured the amount of drug removed by hemodialysis from time 0 to 1 hour after the start of hemodialysis; Arem (1-2), measured the amount of drug removed by hemodialysis from time 1 to 2 hours after the start of hemodialysis; Arem(2-3) ), measured the amount of drug removed by hemodialysis from time 2 to 3 hour, Arem (3-4), measured the amount of drug removed by hemodialysis from hemodialysis from time 3 to 4 hours after the start of hemodialysis (or to the end of dialysis if <4 hours). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram | Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1Dialysate fluid were collected at 1, 2, 3, and 4 hours post-dose in Period 1 only |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Moderate, Part 1 | The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Severe/ESRD Not on Hemodialysis, Part 1 | The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR < 30 milliliter per minute per 1.73 meter^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | ESRD on Hemodialysis (Before Hemodialysis) | The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (treatment period 1). | 0 | 8 | 0 | 8 | 4 | 8 |
| EG004 | ESRD on Hemodialysis (After Hemodialysis) | The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2). | 0 | 8 | 0 | 8 | 3 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Suprapubic pain | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ratio of geometric LS means |
| 4.075 |
| 2-Sided |
| 90 |
| 2.438 |
| 6.810 |
AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis) |
| Other |
| Ratio of geometric LS means |
| 1.575 |
| 2-Sided |
| 90 |
| 0.624 |
| 3.975 |
Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis |
| Other |
| Ratio of geometric LS means |
| 5.966 |
| 2-Sided |
| 90 |
| 2.363 |
| 15.062 |
Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis) |
| Other |
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| Day 1 - 1.5 hour, Abnormal, NCS |
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| Day 1- 1.5 hour, Abnormal, CS |
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| Day 1- 2 hour, Abnormal, NCS |
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| Day 1- 2 hour, Abnormal, CS |
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| Day 1 - 4 hour, Abnormal, NCS |
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| Day 1- 4 hour, Abnormal CS |
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| Day 1 - 8 hour, Abnormal NCS |
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| Day 1 - 8 hour, Abnormal, CS |
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| Day 1 - 12 hour, Abnormal NCS |
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| Day 1 - 12 hour, Abnormal, CS |
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| Day 2 - 24 hour, Abnormal NCS |
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| Day 2 - 24 hour, Abnormal, CS |
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| Day 2 - 36 hour, Abnormal NCS |
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| Day 2 - 36 hour, Abnormal, CS |
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| Day 3 - 48 hour, Abnormal NCS |
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| Day3 - 48 hour, Abnormal, CS |
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| Follow-up, Abnormal NCS |
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| Follow-up, Abnormal CS |
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| Day 1 - Baseline, Abnormal NCS (n=8,8) |
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| Day 1- 2 hour, Abnormal, NCS (n=8,0) |
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| Day 1- 2 hour, Abnormal, CS (n=8,0) |
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| Day 1 - 4 hour, Abnormal, NCS (n=8,0) |
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| Day 1- 4 hour, Abnormal CS (n=8,0) |
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| Day 1 - 8 hour, Abnormal NCS (n=8,0) |
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| Day 1 - 8 hour, Abnormal, CS (n=8,0) |
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| Day 1 - 12 hour, Abnormal NCS (n=8,0) |
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| Day 1 - 12 hour, Abnormal, CS (n=8,0) |
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| Day 2 - 24 hour, Abnormal NCS (n=8,0) |
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| Day 2 - 24 hour, Abnormal, CS (n=8,0) |
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| Day 2 - 36 hour, Abnormal NCS (n=8,0) |
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| Day 2 - 36 hour, Abnormal, CS (n=8,0) |
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| Day 3 - 48 hour, Abnormal NCS (n=8,0) |
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| Day3 - 48 hour, Abnormal, CS (n=8,0) |
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| Day 8- 2 hour, Abnormal, NCS (n=0,8) |
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| Day 8- 2 hour, Abnormal, CS (n=0,8) |
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| Day 8 - 4 hour, Abnormal, NCS (n=0,8) |
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| Day 8- 4 hour, Abnormal CS (n=0,8) |
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| Day 8 - 8 hour, Abnormal NCS (n=0,8) |
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| Day 8 - 8 hour, Abnormal, CS (n=0,8) |
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| Day 8 - 12 hour, Abnormal NCS (n=0,8) |
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| Day 8 - 12 hour, Abnormal, CS (n=0,8) |
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| Day 9- 24 hour, Abnormal, NCS (n=0,8) |
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| Day 9- 24 hour, Abnormal, CS (n=0,8) |
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| Day 9 - 36 hour, Abnormal, NCS (n=0,8) |
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| Day 9- 36 hour, Abnormal CS (n=0,8) |
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| Day 10 - 48 hour, Abnormal NCS (n=0,8) |
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| Day 10 - 48 hour, Abnormal, CS (n=0,8) |
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| Follow-up, Abnormal NCS (n=0,8) |
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| Follow-up, Abnormal CS (n=0,8) |
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| SBP, Day 1 - 4 hour |
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| SBP, Day 1 - 8 hour, |
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| SBP, Day 1 - 12 hour, |
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| SBP, Day 2 - 24 hour, |
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| SBP, Day 2 - 36 hour |
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| SBP, Day 3 - 48 hour |
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| SBP, Follow-up |
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| DBP, Day 1- 1.5 hour |
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| DBP, Day 1- 2 hour, |
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| DBP, Day 1 - 4 hour |
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| DBP, Day 1 - 8 hour |
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| DBP, Day 1 - 12 hour |
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| DBP, Day 2 - 24 hour |
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| DBP, Day 2 - 36 hour |
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| DBP, Day 3 - 48 hour |
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| DBP, Follow-up |
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| SBP, Day 1 - 8 hour, (n=8) |
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| SBP, Day 1 - 12 hour, (n=8) |
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| SBP, Day 2 - 24 hour, (n=8) |
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| SBP, Day 2 - 36 hour (n=8) |
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| SBP, Day 3 - 48 hour, (n=8) |
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| SBP, Day 8-2 hour (n=8) |
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| SBP, Day 8-4 hour (n=8) |
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| SBP, Day 8-8 hour (n=8) |
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| SBP, Day 8-12 hour (n=6) |
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| SBP, Day 9-24 hour (n=8) |
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| SBP, Day 9-36 hour (n=8) |
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| SBP, Day 10-48 hour (n=8) |
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| SBP, Follow-up, (n=8) |
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| DBP, Day 1- 2 hour, (n=8) |
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| DBP, Day 1 - 4 hour, (n=8) |
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| DBP, Day 1 - 8 hour, (n=8) |
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| DBP, Day 1 - 12 hour (n=8) |
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| DBP, Day 2 - 24 hour (n=8) |
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| DBP, Day 2 - 36 hour,(n=8) |
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| DBP, Day 3 - 48 hour (n=7) |
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| DBP, Day 8-2 hour, (n=8) |
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| DBP, Day 8-4 hour , (n=8) |
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| DBP, Day 8- 8 hour,(n=8) |
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| DBP, Day 8-12 hour, (n=8) |
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| DBP, Day 9-24 hour, (n=8) |
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| DBP, Day 9-36 hour (n=8) |
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| DBP, Day 10-48 hour (n=8) |
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| DBP, Follow-up (n=8) |
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| Pulse rate, Day 1 - 4 hour |
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| Pulse rate, Day 1 - 8 hour |
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| Pulse rate, Day 1 - 12 hour |
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| Pulse rate, Day 2 - 24 hour |
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| Pulse rate, Day 2 - 36 hour |
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| Pulse rate, Day 3 - 48 hour |
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| Pulse rate, Follow-up |
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| Pulse rate, Day 1 - 8 hour, (n=8) |
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| Pulse rate, Day 1 - 12 hour, (n=7) |
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| Pulse rate, Day 2 - 24 hour, (n=8) |
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| Pulse rate, Day 2 - 36 hour, (n=8) |
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| Pulse rate, Day 3 - 48 hour, (n=7) |
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| Pulse rate, Day, 8-2 hour (n=8) |
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| Pulse rate, Day 8-4 hour (n=7) |
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| Pulse rate, Day 8-8 hour ,(n=8) |
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| Pulse rate, Day 8-12 hour (n=8) |
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| Pulse rate, Day 9-24 hour (n=8) |
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| Pulse rate, Day9-36 hour (n=8) |
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| Pulse rate, Day 10-48 hour (n=8) |
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| Pulse rate, Follow-up (n=8) |
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| Title | Measurements |
|---|---|
|
|
| Ratio of geometric LS means |
| 1.912 |
| 2-Sided |
| 90 |
| 1.139 |
| 3.212 |
Normal Vs Severe/ESRD not on hemodialysis |
| Other |
| Ratio of geometric LS means |
| 4.068 |
| 2-Sided |
| 90 |
| 2.422 |
| 6.831 |
Normal Vs ESRD on hemodialysis (after hemodialysis) |
| Other |
| Title | Measurements |
|---|---|
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| Ae (6-8) |
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| Ae (8-12) |
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| Ae(12-24) |
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| Ae(24-36) |
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| Ae(36-48) |
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| Ae (6-12) (n=8, 8) |
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| Ae (12-24) (n=8, 8) |
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| Ae(24-36 (n=8, 8) |
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| Ae(36-48) (n=8,7) |
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| Ae (8-12) (n=8,3,3) |
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| Ae (12-24) (n=8,3, 3) |
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| Ae (24-36) (n=8,2,1) |
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| Ae (36-48) (n=8,2,0) |
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| Arem (2-3), (n=8) |
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| Arem (3-4), (n=6) |
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