Gonorrhea
Conditions
Keywords
Urogenital Gonorrhea, Gepotidacin, Neisseria gonorrhoeae, Efficacy, Phase 3
Brief summary
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.
Interventions
DRUGGepotidacin
Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.
DRUGCeftriaxone
Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site.
DRUGAzithromycin
Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be \>=12 years of age at the time of signing the informed consent. * Participants having body weight of \>45 kilogram (kg). * Participants having clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male participants with purulent yellow, green, or white urethral discharge or female participants with abnormal cervical or vaginal mucopurulent discharge upon physical examination; or a prior positive culture for N. gonorrhoeae from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a Gram or equivalent stain (urogenital specimens only) positive or presumptive for Gram-negative intracellular diplococci from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a prior positive nucleic acid amplification test assay for N. gonorrhoeae from up to 7 days before screening (as long as the participant has not received any treatment for this infection). * Participants who are willing to avoid anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit. * Male or female participants having his or her original urogenital anatomy at birth. * Male participant must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit. * Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance (male partners of WOCBP must use a male condom during intercourse) from the Baseline Visit through completion of the TOC Visit. * Participants who are capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or assent form and in study protocol.
Exclusion criteria
* Male participants with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit. * Participant who is suspected or confirmed to have a Chlamydia trachomatis infection and per the investigator's judgement standard-of-care treatment for this infection cannot be safely postponed until the TOC Visit. * Participant has a body mass index \>=40 kilogram per square meter (kg/m\^2) or has a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as high blood pressure or diabetes. * Participant has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation. * Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications. * Participants with a known cluster of differentiation 4 (CD4) count of \<200 cells per cubic millimeter (cells/mm\^3). * Participant has any of the following: poorly controlled asthma or chronic obstructive pulmonary disease, acute severe pain, uncontrolled with conventional medical management, active peptic ulcer disease, Parkinson disease, Myasthenia gravis, a history of seizure disorder requiring medications for control or participant has any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment. * Participant has known anuria, oliguria, or severe impairment of renal function (creatinine clearance \<30 milliliter per minute \[mL/min\] or clinically significant elevated serum creatinine as determined by the investigator). * Participant in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. * Participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period. * Participant has congenital long QT syndrome or known prolongation of corrected QT interval (QTc). * Participant has uncompensated heart failure. * Participant has severe left ventricular hypertrophy. * Participant has a family history of QT prolongation or sudden death. * Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months. * The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org Known Risk of TdP category at the time of his or her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor. * For any participant \>=12 to \<18 years, the participant has an abnormal electrocardiogram (ECG) reading. * The participant has a QTc \>450 millisecond (msec) or a QTc \>480 msec for participants with bundle-branch block. * Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. * Participant has a known history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin. * Participant has a known alanine aminotransferase (ALT) value \>2 times upper limit of normal (ULN). * Participant has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C). * Participant has been previously randomized in this study or has previously been treated with Gepotidacin. * Participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer. * Participant has any of the following gonococcal infections that require a different dose or duration of treatment: suspected or confirmed pelvic inflammatory disease; or suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcal conjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidence of disseminated gonococcal infection. * Participant has received any antibacterial therapy for the treatment of a gonococcal infection within 14 days before the Baseline Visit. * Participant has received any systemic, topical, or intravaginal antibiotics or any systemic antifungals within 7 days before the Baseline Visit. * Participant must not use St John's wort or ergot derivatives from within 14 days before the Baseline Visit through the TOC Visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Up to 21 days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. |
| Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Baseline (Day 1) and TOC visit (Day 4 to 8) | Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit. |
| Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Number of Participants With Urinalysis Dipstick Results | Baseline (Day 1) and TOC visit (Day 4 to 8) | Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and \>=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Absolute Values in Specific Gravity of Urine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Absolute Values in Potential of Hydrogen (pH) of Urine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1) and TOC visit (Day 4 to 8) | SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day 1) and TOC visit (Day 4 to 8) | Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Vital Sign: Temperature | Baseline (Day 1) and TOC visit (Day 4 to 8) | Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Baseline (Day 1) and TOC visit (Day 4 to 8) | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
Countries
Australia, Germany, Mexico, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water. | 314 |
| Ceftriaxone Plus Azithromycin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water. | 314 |
| Total | 628 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Eligibility Criteria Unable to Evaluate | 1 | 0 |
| Overall Study | Lost to Follow-up | 10 | 14 |
| Overall Study | Participant Did Not Receive IP | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Deviation | 0 | 1 |
| Overall Study | Randomized in Error/ Mistake | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Ceftriaxone Plus Azithromycin | Total | Gepotidacin |
|---|---|---|---|
| Age, Continuous | 33.7 Years STANDARD_DEVIATION 10.7 | 33.8 Years STANDARD_DEVIATION 10.56 | 33.9 Years STANDARD_DEVIATION 10.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 29 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 88 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 241 Participants | 472 Participants | 231 Participants |
| Sex: Female, Male Female | 34 Participants | 69 Participants | 35 Participants |
| Sex: Female, Male Male | 280 Participants | 559 Participants | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 309 | 0 / 313 |
| other Total, other adverse events | 230 / 309 | 81 / 313 |
| serious Total, serious adverse events | 1 / 309 | 0 / 313 |
Outcome results
Primary
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8)
Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Microbiological intent-to-treat (Micro-ITT) population included all participants randomly assigned to study treatment who received at least 1 dose of study treatment and have confirmed NG isolated that is ceftriaxone-susceptible (based on CLSI breakpoints) from baseline culture of their urogenital specimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological success | 187 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological failure, BP | 0 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological failure, UTD | 15 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological success | 186 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological failure, BP | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) | Microbiological failure, UTD | 18 Participants |
95% CI: [-5.6, 5.5]
p-value: 0.507295% CI: [-5.6, 5.5]1-sided p-value for Test of Superiority
Secondary
Absolute Values in Potential of Hydrogen (pH) of Urine
Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Absolute Values in Potential of Hydrogen (pH) of Urine | Baseline (Day 1) | 5.6 pH | Standard Deviation 0.69 |
| Gepotidacin | Absolute Values in Potential of Hydrogen (pH) of Urine | TOC | 5.5 pH | Standard Deviation 0.64 |
| Ceftriaxone Plus Azithromycin | Absolute Values in Potential of Hydrogen (pH) of Urine | Baseline (Day 1) | 5.6 pH | Standard Deviation 0.7 |
| Ceftriaxone Plus Azithromycin | Absolute Values in Potential of Hydrogen (pH) of Urine | TOC | 5.4 pH | Standard Deviation 0.62 |
Secondary
Absolute Values in Specific Gravity of Urine
Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Absolute Values in Specific Gravity of Urine | Baseline (Day 1) | 1.0211 Ratio | Standard Deviation 0.0075 |
| Gepotidacin | Absolute Values in Specific Gravity of Urine | TOC | 1.0211 Ratio | Standard Deviation 0.0072 |
| Ceftriaxone Plus Azithromycin | Absolute Values in Specific Gravity of Urine | Baseline (Day 1) | 1.0207 Ratio | Standard Deviation 0.00747 |
| Ceftriaxone Plus Azithromycin | Absolute Values in Specific Gravity of Urine | TOC | 1.0216 Ratio | Standard Deviation 0.00748 |
Secondary
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes
Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Basophils, Baseline (Day 1) | 0.044 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0196 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Basophils, CFB to TOC | 0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0167 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Eosinophils, Baseline (Day 1) | 0.154 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.2117 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Eosinophils, CFB to TOC | 0.009 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1289 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Leukocytes, Baseline (Day 1) | 7.143 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.2808 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Leukocytes, CFB to TOC | -0.811 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.8536 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Neutrophils, Baseline (Day 1) | 4.443 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.9621 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Neutrophils, CFB to TOC | -1.062 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.7309 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Platelets, Baseline (Day 1) | 260.3 Giga cells per liter (10^9 cells/L) | Standard Deviation 61.79 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Platelets, CFB to TOC | 10.2 Giga cells per liter (10^9 cells/L) | Standard Deviation 32.14 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Lymphocytes, Baseline (Day 1) | 1.934 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5941 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Lymphocytes, CFB to TOC | 0.277 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5205 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Monocytes, Baseline (Day 1) | 0.559 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.2209 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Monocytes, CFB to TOC | -0.034 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1917 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Nucleated Erythrocytes, Baseline (Day 1) | 0.002 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0047 |
| Gepotidacin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Nucleated Erythrocytes, CFB to TOC | 0.000 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.007 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Nucleated Erythrocytes, CFB to TOC | 0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0059 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Basophils, Baseline (Day 1) | 0.045 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0222 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Platelets, Baseline (Day 1) | 268.4 Giga cells per liter (10^9 cells/L) | Standard Deviation 69.26 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Basophils, CFB to TOC | 0.000 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0152 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Monocytes, Baseline (Day 1) | 0.572 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1877 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Eosinophils, Baseline (Day 1) | 0.160 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1384 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Platelets, CFB to TOC | 9.7 Giga cells per liter (10^9 cells/L) | Standard Deviation 34.94 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Eosinophils, CFB to TOC | 0.018 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0827 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Nucleated Erythrocytes, Baseline (Day 1) | 0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0038 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Leukocytes, Baseline (Day 1) | 7.507 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.2045 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Lymphocytes, Baseline (Day 1) | 1.948 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.6321 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Leukocytes, CFB to TOC | -1.267 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.9362 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Monocytes, CFB to TOC | -0.053 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1782 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Neutrophils, Baseline (Day 1) | 4.774 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.9355 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Lymphocytes, CFB to TOC | 0.245 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5511 |
| Ceftriaxone Plus Azithromycin | Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes | Neutrophils, CFB to TOC | -1.473 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.886 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, Baseline (Day 1) | 46.9 Grams per liter (g/L) | Standard Deviation 3.12 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, CFB to TOC | -0.3 Grams per liter (g/L) | Standard Deviation 2.35 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, Baseline (Day 1) | 73.1 Grams per liter (g/L) | Standard Deviation 4.8 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, CFB to TOC | -0.5 Grams per liter (g/L) | Standard Deviation 3.86 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, CFB to TOC | -0.5 Grams per liter (g/L) | Standard Deviation 4.02 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, Baseline (Day 1) | 46.8 Grams per liter (g/L) | Standard Deviation 3.19 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein, Baseline (Day 1) | 73.3 Grams per liter (g/L) | Standard Deviation 4.85 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin, CFB to TOC | -0.3 Grams per liter (g/L) | Standard Deviation 2.67 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | AST, Baseline (Day 1) | 24.4 International units per Liter (IU/L) | Standard Deviation 15.3 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | AST, CFB to TOC | 2.8 International units per Liter (IU/L) | Standard Deviation 19.51 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALT, Baseline (Day 1) | 23.7 International units per Liter (IU/L) | Standard Deviation 18.78 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALT, CFB to TOC | 1.4 International units per Liter (IU/L) | Standard Deviation 12.59 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALP, Baseline (Day 1) | 76.0 International units per Liter (IU/L) | Standard Deviation 20.86 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALP, CFB to TOC | -0.4 International units per Liter (IU/L) | Standard Deviation 7.73 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALP, Baseline (Day 1) | 77.1 International units per Liter (IU/L) | Standard Deviation 26.53 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | AST, Baseline (Day 1) | 24.2 International units per Liter (IU/L) | Standard Deviation 16.29 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALT, CFB to TOC | 1.1 International units per Liter (IU/L) | Standard Deviation 7.64 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | AST, CFB to TOC | 0.9 International units per Liter (IU/L) | Standard Deviation 13.25 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALP, CFB to TOC | -1.5 International units per Liter (IU/L) | Standard Deviation 7.8 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) | ALT, Baseline (Day 1) | 23.7 International units per Liter (IU/L) | Standard Deviation 14.35 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Baseline (Day 1) | 8.54 Micromoles per liter (umol/L) | Standard Deviation 5.861 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, CFB to TOC | -0.05 Micromoles per liter (umol/L) | Standard Deviation 5.025 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Direct Bilirubin, Baseline (Day 1) | 3.83 Micromoles per liter (umol/L) | Standard Deviation 1.248 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Direct Bilirubin, CFB to TOC | -0.02 Micromoles per liter (umol/L) | Standard Deviation 0.897 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Baseline (Day 1) | 75.9 Micromoles per liter (umol/L) | Standard Deviation 34.12 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, CFB to TOC | -0.2 Micromoles per liter (umol/L) | Standard Deviation 34.08 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Baseline (Day 1) | 75.0 Micromoles per liter (umol/L) | Standard Deviation 20.63 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Baseline (Day 1) | 7.71 Micromoles per liter (umol/L) | Standard Deviation 4.806 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Direct Bilirubin, CFB to TOC | 0.01 Micromoles per liter (umol/L) | Standard Deviation 0.876 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, CFB to TOC | -0.14 Micromoles per liter (umol/L) | Standard Deviation 3.914 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, CFB to TOC | 2.6 Micromoles per liter (umol/L) | Standard Deviation 9.52 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine | Direct Bilirubin, Baseline (Day 1) | 3.76 Micromoles per liter (umol/L) | Standard Deviation 1.21 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | UN, Baseline (Day 1) | 4.793 Millimoles per liter (mmol/L) | Standard Deviation 1.4293 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | UN, CFB to TOC | 0.190 Millimoles per liter (mmol/L) | Standard Deviation 1.164 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Glucose, Baseline | 5.049 Millimoles per liter (mmol/L) | Standard Deviation 1.0557 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Glucose, CFB to TOC | 0.227 Millimoles per liter (mmol/L) | Standard Deviation 0.9425 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Calcium, Baseline (Day 1) | 2.387 Millimoles per liter (mmol/L) | Standard Deviation 0.0986 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Calcium, CFB to TOC | -0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.0852 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Chloride, Baseline (Day 1) | 101.7 Millimoles per liter (mmol/L) | Standard Deviation 2.26 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Chloride, CFB to TOC | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.57 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Sodium, Baseline (Day 1) | 139.6 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Sodium, CFB to TOC | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Magnesium, Baseline (Day 1) | 0.854 Millimoles per liter (mmol/L) | Standard Deviation 0.0612 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Magnesium, CFB to TOC | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.0604 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Potassium, Baseline (Day 1) | 4.29 Millimoles per liter (mmol/L) | Standard Deviation 0.323 |
| Gepotidacin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Potassium, CFB to TOC | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.336 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Magnesium, Baseline (Day 1) | 0.855 Millimoles per liter (mmol/L) | Standard Deviation 0.0637 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | UN, Baseline (Day 1) | 4.800 Millimoles per liter (mmol/L) | Standard Deviation 1.4669 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Chloride, CFB to TOC | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.4 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | UN, CFB to TOC | 0.282 Millimoles per liter (mmol/L) | Standard Deviation 1.192 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Potassium, Baseline (Day 1) | 4.30 Millimoles per liter (mmol/L) | Standard Deviation 0.332 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Glucose, Baseline | 5.090 Millimoles per liter (mmol/L) | Standard Deviation 1.1183 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Sodium, Baseline (Day 1) | 139.6 Millimoles per liter (mmol/L) | Standard Deviation 2.02 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Glucose, CFB to TOC | 0.064 Millimoles per liter (mmol/L) | Standard Deviation 0.9684 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Magnesium, CFB to TOC | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.0584 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Calcium, Baseline (Day 1) | 2.387 Millimoles per liter (mmol/L) | Standard Deviation 0.0954 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Sodium, CFB to TOC | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.44 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Calcium, CFB to TOC | -0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.0871 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Potassium, CFB to TOC | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.345 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium | Chloride, Baseline (Day 1) | 101.7 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) | 4.911 Trillion cells per liter (10^12 cells/L) | Standard Deviation 0.4722 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Erythrocytes | CFB to TOC | 0.003 Trillion cells per liter (10^12 cells/L) | Standard Deviation 0.2261 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1) | 4.926 Trillion cells per liter (10^12 cells/L) | Standard Deviation 0.4601 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Erythrocytes | CFB to TOC | 0.019 Trillion cells per liter (10^12 cells/L) | Standard Deviation 0.2332 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) | 0.4691 Percentage | Standard Deviation 0.04205 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Hematocrit | CFB to TOC | -0.0038 Percentage | Standard Deviation 0.02526 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1) | 0.4687 Percentage | Standard Deviation 0.04104 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Hematocrit | CFB to TOC | 0.0012 Percentage | Standard Deviation 0.02666 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) | 30.46 Picograms (pg) | Standard Deviation 1.978 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | CFB to TOC | -0.03 Picograms (pg) | Standard Deviation 0.451 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | Baseline (Day 1) | 30.38 Picograms (pg) | Standard Deviation 1.987 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) | CFB to TOC | 0.00 Picograms (pg) | Standard Deviation 0.594 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) | 95.79 Femtoliters (fL) | Standard Deviation 6.266 |
| Gepotidacin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | CFB to TOC | -0.85 Femtoliters (fL) | Standard Deviation 3.104 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | Baseline (Day 1) | 95.43 Femtoliters (fL) | Standard Deviation 6.76 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) | CFB to TOC | -0.12 Femtoliters (fL) | Standard Deviation 3.084 |
Secondary
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)
Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | MCHC, Baseline (Day 1) | 318.5 Grams per liter (g/L) | Standard Deviation 16.27 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | MCHC, CFB to TOC | 2.4 Grams per liter (g/L) | Standard Deviation 10.67 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Hb, Baseline (Day 1) | 149.1 Grams per liter (g/L) | Standard Deviation 12.83 |
| Gepotidacin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Hb, CFB to TOC | 0.00 Grams per liter (g/L) | Standard Deviation 6.7 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Hb, CFB to TOC | 0.6 Grams per liter (g/L) | Standard Deviation 6.92 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | MCHC, Baseline (Day 1) | 318.8 Grams per liter (g/L) | Standard Deviation 16.12 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Hb, Baseline (Day 1) | 149.2 Grams per liter (g/L) | Standard Deviation 12.58 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | MCHC, CFB to TOC | 0.3 Grams per liter (g/L) | Standard Deviation 11.27 |
Secondary
Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day 1) | 73.0 Beats per minute | Standard Deviation 12.24 |
| Gepotidacin | Change From Baseline in Vital Sign: Pulse Rate | CFB to TOC | 2.2 Beats per minute | Standard Deviation 12.44 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day 1) | 72.8 Beats per minute | Standard Deviation 12.2 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Sign: Pulse Rate | CFB to TOC | 2.4 Beats per minute | Standard Deviation 12.33 |
Secondary
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Day 1) | 123.9 Millimeters of mercury (mmHg) | Standard Deviation 13.69 |
| Gepotidacin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, CFB to TOC | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Gepotidacin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Day 1) | 76.7 Millimeters of mercury (mmHg) | Standard Deviation 10.77 |
| Gepotidacin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, CFB to TOC | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 9.1 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, CFB to TOC | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 9.54 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Baseline (Day 1) | 125.1 Millimeters of mercury (mmHg) | Standard Deviation 14.41 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Baseline (Day 1) | 77.2 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, CFB to TOC | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 12.86 |
Secondary
Change From Baseline in Vital Sign: Temperature
Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin | Change From Baseline in Vital Sign: Temperature | Baseline (Day 1) | 36.45 Celsius (C) | Standard Deviation 0.395 |
| Gepotidacin | Change From Baseline in Vital Sign: Temperature | CFB to TOC | -0.03 Celsius (C) | Standard Deviation 0.381 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Sign: Temperature | Baseline (Day 1) | 36.44 Celsius (C) | Standard Deviation 0.457 |
| Ceftriaxone Plus Azithromycin | Change From Baseline in Vital Sign: Temperature | CFB to TOC | -0.06 Celsius (C) | Standard Deviation 0.485 |
Secondary
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
Time frame: Up to 21 days
Population: Safety population included all participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Any TEAEs | 230 Participants |
| Gepotidacin | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Any TEAEs | 104 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit
Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Micro-ITT Pharyngeal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological success | 14 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological failure, BP | 2 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological failure, UTD | 2 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological success | 16 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological failure, BP | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit | Microbiological failure, UTD | 1 Participants |
Secondary
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit
Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as Bacterial Persistence (BP) and Unable to Determine (UTD) outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Micro-ITT Rectal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological success | 26 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological failure, BP | 0 Participants |
| Gepotidacin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological failure, UTD | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological success | 12 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological failure, BP | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit | Microbiological failure, UTD | 3 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results
Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and \>=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1) and TOC visit (Day 4 to 8)
Population: Safety population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Moderate | 18 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, 150 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Large | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), 20 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Negative | 251 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), >=500 mg/dL | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Small | 30 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, Negative | 279 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Moderate | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, >=500 mg/dL | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Large | 3 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, 5 mg/dL | 7 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), Negative | 212 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), 150 mg/dL | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), 30 mg/dL | 79 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, 20 mg/dL | 1 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), 100 mg/dL | 8 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), Negative | 288 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), >=500 mg/dL | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Negative | 202 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, Negative | 239 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), Negative | 296 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, 30 mg/dL | 46 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Small | 77 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, 100 mg/dL | 2 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), 5 mg/dL | 10 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, >=500 mg/dL | 0 Participants |
| Gepotidacin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, Negative | 284 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, >=500 mg/dL | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), Negative | 305 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), 150 mg/dL | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, Baseline (Day 1), >=500 mg/dL | 2 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, Negative | 283 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, 150 mg/dL | 1 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Glucose, TOC, >=500 mg/dL | 1 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), Negative | 300 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), 5 mg/dL | 7 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, Baseline (Day 1), 20 mg/dL | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, Negative | 279 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, 5 mg/dL | 6 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Ketones, TOC, 20 mg/dL | 0 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Negative | 192 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Small | 91 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Moderate | 19 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, Baseline (Day 1), Large | 5 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Negative | 252 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Small | 24 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Moderate | 6 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Occult Blood, TOC, Large | 3 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), Negative | 210 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), 30 mg/dL | 83 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), 100 mg/dL | 13 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, Baseline (Day 1), >=500 mg/dL | 1 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, Negative | 244 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, 30 mg/dL | 37 Participants |
| Ceftriaxone Plus Azithromycin | Number of Participants With Urinalysis Dipstick Results | Protein, TOC, 100 mg/dL | 4 Participants |