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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201500005I |
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The Phase I Thorough QT/QTc (TQT) study will be performed in a single center, the Vince & Associates Clinical Research, Inc., clinical trials unit (CTU), in 72 healthy male or female subjects, aged 18 to 45 years inclusive, to evaluate the effect of zoliflodacin on the corrected QT interval of the electrocardiogram (ECG) using Fridericia's Formula (QTcF) and other ECG parameters; the correlation of the drug concentrations (and pharmacokinetic (PK) profile) with time-matched, placebo-corrected, baseline-adjusted difference in QTcF interval (delta delta QTcF); and the PK and safety profiles of the new zoliflodacin formulation. Each subject will receive one dose of each of four treatments: zoliflodacin 2 g orally, zoliflodacin 4 g orally, placebo for zoliflodacin 4 g orally, and moxifloxacin 400 mg orally. The study will last approximately 12 weeks with a subject participation duration of up to 55 days. The primary hypothesis to be tested is that following administration of zoliflodacin 2 g and 4 g, the upper bound of the one-sided 95% confidence interval (CI) of treatment effect on delta delta QTcF is > / = 10 msec for at least one of the ECG assessments, against the alternative hypothesis that all mean effects are < 10 msec. The primary objective is to evaluate the effect of zoliflodacin on the corrected QT interval of the ECG using Fridericia's formula (QTcF).
The Phase I Thorough QT/QTc (TQT) study will be performed in a single center, the Vince & Associates Clinical Research, Inc., clinical trials unit (CTU), according to a randomized, double-blinded (except for the use of moxifloxacin), placebo-controlled, four-period, four-treatment, crossover design balanced with respect to first-order carryover effect in 72 healthy male or female subjects, aged 18 to 45 years inclusive, to evaluate the effect of zoliflodacin on the corrected QT interval of the electrocardiogram (ECG) using Fridericia's Formula (QTcF) and other ECG parameters; the correlation of the drug concentrations (and pharmacokinetic (PK) profile) with time-matched, placebo-corrected, baseline-adjusted difference in QTcF interval (delta delta QTcF); and the PK and safety profiles of the new zoliflodacin formulation. Each subject will receive one dose of each of four treatments: zoliflodacin 2 g orally, zoliflodacin 4 g orally, placebo for zoliflodacin 4 g orally, and moxifloxacin 400 mg orally. The study will last approximately 12 weeks with a subject participation duration of up to 55 days. The primary hypothesis to be tested is that following administration of zoliflodacin 2 g and 4 g, the upper bound of the one-sided 95% confidence interval (CI) of treatment effect on delta delta QTcF is > / = 10 msec for at least one of the ECG assessments, against the alternative hypothesis that all mean effects are < 10 msec. The primary objective is to evaluate the effect of zoliflodacin on the corrected QT interval of the ECG using Fridericia's formula (QTcF). The secondary objectives are: 1) to evaluate the effects of zoliflodacin on other ECG parameters (PR, QRS, and RR intervals, and heart rate (HR)); 2) to evaluate the sensitivity of QTcF measurement using moxifloxacin; 3) to evaluate the effect of zoliflodacin on T-wave morphology; 4) to evaluate the PK of 2 g and 4 g oral zoliflodacin under fasting state; 5) to evaluate the relationship between zoliflodacin PK and time-matched QTcF pharmacodynamics (PD); 6) to evaluate the safety and tolerability of 2 g and 4 g oral zoliflodacin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 2 g of zoliflodacin administered orally on Day 1 of each dosing period, n=72 |
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| Treatment B | Experimental | 4 g of zoliflodacin administered orally on Day 1 of each dosing period, n=72 |
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| Treatment C | Placebo Comparator | Placebo for zoliflodacin administered orally on Day 1 of each dosing period, n=72 |
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| Treatment D | Active Comparator | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period, n=72 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0914 | Drug | Spiropyrimidinetrione antibacterial drug, which inhibits bacterial DNA synthesis by a novel mechanism. Powder will be reconstituted in 60 mL of tap water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin is taken, approximately 60 mL of tap water will be added to the cup and consumed by the subject to chase the initial dose. |
| Measure | Description | Time Frame |
|---|---|---|
| The One-sided 95% Confidence Interval (CI) for the Largest Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose after 2 and 4 g zolifloadacin |
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline heart rate by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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Inclusion Criteria:
All must be answered YES for the subject to be eligible for study participation:
Informed consent form (ICF) understood and signed before initiating any study procedures
Healthy male or female, as assessed by authorized site clinician (listed on FDA Form 1572)
Willingness to comply with and be available for all protocol procedures, including inpatient confinement for 3 days in each dosing period and follow-up for the duration of the trial
Aged 18 to 45 years inclusive on the day of first dosing
Body Mass Index (BMI) > / = 18.5 and < / = to 30 kg per m^2 and weight > / = 50 kg (110 lbs.) and < / = 100 kg (220 lbs.)
In all female subjects, whether of childbearing potential or post-menopausal by medical history (MH), a negative serum pregnancy test at Screening Visit and on Day -1 of each dosing period
-Note: A woman is considered of childbearing potential unless post-menopausal (> / = 1 year without menses without other known or suspected cause and with a FSH level in the menopausal range), or surgically sterilized (hysterectomy, salpingectomy, oophorectomy, or tubal ligation/occlusion).
If female, not pregnant, not breast feeding, and not planning to become pregnant during the trial and for 30 days after Final Visit
Females of childbearing potential and males agree to use acceptable contraception for the duration of the trial and for 30 days (females) or 90 days (males) after Final Visit
-Note: A highly effective method of birth control is defined as one with a low failure rate (i.e., less than 1 percent per year) according to CDC criteria. These include progestin implants, intrauterine devices (IUDs), surgical (hysterectomy, salpingectomy, oophorectomy, or tubal ligation/occlusion; vasectomy), or abstinence. Use of methods with higher failure rate (such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms) will not be acceptable when used alone, but they could be considered if used in combination with another method (e.g., a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the DMID Medical Officer.
Male subjects agree to refrain from sperm donation for the duration of the trial and for 90 days after Final Visit
Laboratory tests are in the normal reference range with acceptable exceptions
Vital signs (VS) are within the acceptable range
Has adequate venous access for blood collection
Urine drug screen is negative for tested substances
Urine alcohol test is negative
Willing to abstain from alcohol consumption for 2 days before Day -1 of Period 1 and for the duration of the trial
Exclusion Criteria:
All must be answered NO for the subject to be eligible for study participation:
1. History of acute or chronic cardiovascular disease or surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34606332 | Derived | Newman LM, Kankam M, Nakamura A, Conrad T, Mueller J, O'Donnell J, Osborn BL, Gu K, Saviolakis GA. Thorough QT Study To Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults. Antimicrob Agents Chemother. 2021 Nov 17;65(12):e0129221. doi: 10.1128/AAC.01292-21. Epub 2021 Oct 4. |
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The trial was performed at a commercial phase 1 unit. Recruitment opened on September 4, 2018 and all 72 participants were consented and screened for meeting eligibility criteria prior to enrollment and dosing. Enrollment was completed on December 04, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2g Zoliflodacin, 4g Zoliflodacin, Placebo, 400mg Moxifloxacin | Treatment ABCD: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Treatment |
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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 | Nov 27, 2018 | Dec 24, 2019 |
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| Moxifloxacin | Drug | Broad-spectrum 8-methoxy fluoroquinolone with activity against both Gram-positive and Gram-negative bacteria, including anaerobes. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride will be administered orally with 120 mL of tap water. |
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| Placebo | Other | Composed of 4 g of the same excipients found in zoliflodacin. Powder will be reconstituted in 60 mL of tap water and dosed orally after an overnight fast. After the cup containing 60 mL of placebo is taken, approximately 60 mL of tap water will be added to the cup and consumed by the subject to chase the initial dose. |
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| Time-matched, Placebo-corrected, Baseline-adjusted, the Time From the Onset of the P Wave to the Start of the QRS Complex (PR Interval) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline PR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline RR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QRS durations by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| The One-sided 95% Confidence Interval (CI) of the Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) After a Single Dose of Moxifloxacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Baseline, 1 h, 2 h, 3 h, and 4 h post-dose |
| Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin | Categorical T-wave morphology analysis was collected in three ECG replicates at each timepoint (Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose). Abnormalities present in any one or more of the baseline timepoint replicate ECGs recorded for a particular period was considered to be present at baseline for post-dose ECGs from that specific period. If a subject had an ECG morphological abnormality in more than one replicate ECG of a study timepoint, the subject was counted only once for that timepoint. Flat is defined as T amplitude <1 mm (either positive or negative) including flat isoelectric line and Biphasic is defined as T-wave that contains a second component with an opposite phase that was at least 0.1 millivolts (mV) deep (both positive and negative/positive and polyphasic T-waves included). | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Maximum Observed Concentration (Cmax) of Zoliflodacin | Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method. Pharmacokinetic (PK) parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Time of Maximum Observed Concentration (Tmax) of Zoliflodacin | Tmax is defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0 - Infinity)) for Zoliflodacin | AUC(0 - infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0 - infinity) was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin | AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Apparent Volume of Distribution (Vz/F) of Zoliflodacin | Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Apparent Oral Clearance (CL/F) of Zoliflodacin | Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-infinity) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Elimination Rate Constant (Ke) of Zoliflodacin | The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Terminal Elimination Half-life (t1/2) of Zoliflodacin | The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Relationship Between Plasma Concentrations of Zoliflodacin and Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin | One-sided 95% confidence intervals of population mean QTcF time-matched, placebo-corrected, baseline-adjusted mean QTcF interval at plasma concentration corresponding to the observed geometric mean Cmax for 2 g and 4 g doses of zoliflodacin were computed using a linear mixed effect model with PK and concentration data collected at baseline and intervals post-dose. | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
| Number of Participants With Treatment-emergent Serious Adverse Events Following Administration of Zoliflodacin and Moxifloxacin | Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Number of Participants With Treatment-emergent Adverse Events Following Administration of Study Product | Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Blood Pressure - Systolic | Change from baseline in systolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Blood Pressure - Diastolic | Change from baseline in diastolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Pulse Rate | Change from baseline in pulse rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Respiratory Rate | Change from baseline in respiratory rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Temperature | Change from baseline for temperature was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for White Blood Cells With Differentials | Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Hematology parameters included white blood cell count, and differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils). | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Hemoglobin | Change from baseline for hemoglobin is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Hematocrit | Change from baseline for hematocrit is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Erythrocytes | Change from baseline for erythrocytes is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Platelets | Change from baseline for platelets is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included sodium, potassium. chloride and bicarbonate. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included magnesium, glucose (fasting), BUN, creatinine, total bilirubin, direct bilirubin | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Total Protein and Albumin | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included total protein and albumin. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP) | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included AST, ALT and AP. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline for Glomerular Filtration Rate (GFR) - Estimated | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
| Occurrence of Urinalysis Adverse Events Following Administration of Study Product | Urine for the clinical laboratory test was collected on Day -1, 24 hour post dose and the check in for the following dosing period. The results for glucose dipstick, protein dipstick and occult blood - dipstick were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+. If the dipsticks were 1+ or greater, microscopic evaluations were performed for erythrocytes, leukocytes and bacteria. For microscopic results to be deemed abnormal, the results must be reported 6 or greater per high power field. | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
| Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval | Change from baseline in ECG is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up). The following ECG Parameters were analyzed: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex), QRS Duration (Time From the Start of the Q-wave to the End of the S-wave), QT Interval (Interval From Onset of the Q-wave to the End of the T-wave), QTcF Interval (QT Interval Corrected by Fridericia's Formula) and RR Interval (Interval From the Peak of the R Wave of a QRS Complex to the Peak of the R Wave of the Next QRS Complex). | Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up |
| Changes From Baseline in ECG Measures: Ventricular Rate | Change from baseline in ECG Ventricular Rate is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up). | Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up |
| FG001 | 2g Zoliflodacin, Placebo, 400mg Moxifloxacin, 4g Zoliflodacin | Treatment ACDB: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out, 400 mg moxifloxacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG002 | 2g Zoliflodacin, 400mg Moxifloxacin, 4g Zoliflodacin, Placebo | Treatment ADBC: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 4g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG003 | 4g Zoliflodacin, 2g Zoliflodacin, 400mg Moxifloxacin, Placebo | Treatment BADC: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG004 | 4g Zoliflodacin, 400mg Moxifloxacin, Placebo, 2g Zoliflodacin, | Treatment BDCA: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG005 | 4g Zoliflodacin, Placebo, 2g Zoliflodacin, 400mg Moxifloxacin | Treatment BCAD: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG006 | Placebo, 400mg Moxifloxacin, 2g Zoliflodacin, 4g Zoliflodacin, | Treatment CDAB: Placebo administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG007 | Placebo, 2g Zoliflodacin, 4g Zoliflodacin, 400mg Moxifloxacin | Treatment CABD: Placebo administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG008 | Placebo, 4g Zoliflodacin, 400mg Moxifloxacin, 2g Zoliflodacin | Treatment CBDA: Placebo administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG009 | 400mg Moxifloxacin, Placebo, 4g Zoliflodacin, 2g Zoliflodacin | Treatment DCBA: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG010 | 400mg Moxifloxacin, 4g Zoliflodacin, 2g Zoliflodacin, Placebo | Treatment DBAC: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| FG011 | 400mg Moxifloxacin, 2g Zoliflodacin, Placebo, 4g Zoliflodacin | Treatment DACB: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| Second Treatment |
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| Third Treatment |
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| Fourth Treatment |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2g Zoliflodacin, 4g Zoliflodacin, Placebo, 400mg Moxifloxacin | Treatment ABCD: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG001 | 2g Zoliflodacin, Placebo, 400mg Moxifloxacin, 4g Zoliflodacin | Treatment ACDB: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out, 400 mg moxifloxacin was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water.. |
| BG002 | 2g Zoliflodacin, 400mg Moxifloxacin, 4g Zoliflodacin, Placebo | Treatment ADBC: 2 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 4g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG003 | 4g Zoliflodacin, 2g Zoliflodacin, 400mg Moxifloxacin, Placebo | Treatment BADC: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out2 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG004 | 4g Zoliflodacin, 400mg Moxifloxacin, Placebo, 2g Zoliflodacin, | Treatment BDCA: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG005 | 4g Zoliflodacin, Placebo, 2g Zoliflodacin, 400mg Moxifloxacin | Treatment BCAD: 4 g of zoliflodacin administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG006 | Placebo, 400mg Moxifloxacin, 2g Zoliflodacin, 4g Zoliflodacin, | Treatment CDAB: Placebo administered orally on Day 1, then an 8 day wash out 400mg of moxifloxacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG007 | Placebo, 2g Zoliflodacin, 4g Zoliflodacin, 400mg Moxifloxacin | Treatment CABD: Placebo administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 400mg of moxifloxacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG008 | Placebo, 4g Zoliflodacin, 400mg Moxifloxacin, 2g Zoliflodacin | Treatment CBDA: Placebo administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 400mg of moxifloxacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG009 | 400mg Moxifloxacin, Placebo, 4g Zoliflodacin, 2g Zoliflodacin | Treatment DCBA: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out placebo was taken, then another 8 day wash out 4 g of zoliflodacin was taken and then after the final 8 day wash out 2 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG010 | 400mg Moxifloxacin, 4g Zoliflodacin, 2g Zoliflodacin, Placebo | Treatment DBAC: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 4 g of zoliflodacin was taken, then another 8 day wash out 2 g of zoliflodacin was taken and then after the final 8 day wash out placebo was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG011 | 400mg Moxifloxacin, 2g Zoliflodacin, Placebo, 4g Zoliflodacin | Treatment DACB: 400mg of moxifloxacin was administered orally on Day 1, then an 8 day wash out 2 g of zoliflodacin was taken, then another 8 day wash out placebo was taken and then after the final 8 day wash out 4 g of zoliflodacin was taken. AZD0914: Spiropyrimidinetrione antibacterial drug, Powder was reconstituted in 60 mL of water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin was taken, approximately 60 mL of water was added and consumed by the subject to chase the initial dose. Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
| BG012 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Weight | Mean | Standard Deviation | kiliograms |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The One-sided 95% Confidence Interval (CI) for the Largest Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received a dose of zoliflodacin or a dose of placebo. | Posted | Mean | 90% Confidence Interval | milliseconds (msec) | Baseline, 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose after 2 and 4 g zolifloadacin |
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| Secondary | Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline heart rate by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo. | Posted | Mean | 95% Confidence Interval | beats/minute | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Time-matched, Placebo-corrected, Baseline-adjusted, the Time From the Onset of the P Wave to the Start of the QRS Complex (PR Interval) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline PR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo. | Posted | Mean | 95% Confidence Interval | milliseconds (msec) | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline RR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo. | Posted | Mean | 95% Confidence Interval | milliseconds (msec) | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QRS durations by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo. | Posted | Mean | 95% Confidence Interval | milliseconds (msec) | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | The One-sided 95% Confidence Interval (CI) of the Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) After a Single Dose of Moxifloxacin | Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval. | Any participants who received a dose of moxifloxacin and placebo and had post dose assessments is counted in the population. | Posted | Mean | 95% Confidence Interval | milliseconds (msec) | Baseline, 1 h, 2 h, 3 h, and 4 h post-dose |
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| Secondary | Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin | Categorical T-wave morphology analysis was collected in three ECG replicates at each timepoint (Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose). Abnormalities present in any one or more of the baseline timepoint replicate ECGs recorded for a particular period was considered to be present at baseline for post-dose ECGs from that specific period. If a subject had an ECG morphological abnormality in more than one replicate ECG of a study timepoint, the subject was counted only once for that timepoint. Flat is defined as T amplitude <1 mm (either positive or negative) including flat isoelectric line and Biphasic is defined as T-wave that contains a second component with an opposite phase that was at least 0.1 millivolts (mV) deep (both positive and negative/positive and polyphasic T-waves included). | Any participants who received study product and had post dose assessments. | Posted | Count of Participants | Participants | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Maximum Observed Concentration (Cmax) of Zoliflodacin | Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method. Pharmacokinetic (PK) parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Time of Maximum Observed Concentration (Tmax) of Zoliflodacin | Tmax is defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | hour | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0 - Infinity)) for Zoliflodacin | AUC(0 - infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0 - infinity) was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | h x ng/mL | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin | AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | h*ng/mL | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Zoliflodacin | Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | Liter | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Apparent Oral Clearance (CL/F) of Zoliflodacin | Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-infinity) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | Liter/hour | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Elimination Rate Constant (Ke) of Zoliflodacin | The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | 1/hour | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Terminal Elimination Half-life (t1/2) of Zoliflodacin | The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose. | Posted | Mean | Standard Deviation | Hour | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Relationship Between Plasma Concentrations of Zoliflodacin and Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin | One-sided 95% confidence intervals of population mean QTcF time-matched, placebo-corrected, baseline-adjusted mean QTcF interval at plasma concentration corresponding to the observed geometric mean Cmax for 2 g and 4 g doses of zoliflodacin were computed using a linear mixed effect model with PK and concentration data collected at baseline and intervals post-dose. | Any participants who received study product and had post dose assessments. | Posted | Mean | 95% Confidence Interval | milliseconds (msec) | Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose |
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| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events Following Administration of Zoliflodacin and Moxifloxacin | Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. | Any participants who received study product. | Posted | Count of Participants | Participants | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events Following Administration of Study Product | Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. | Any participants who received study product. | Posted | Count of Participants | Participants | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Blood Pressure - Systolic | Change from baseline in systolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | Any participants who received study product and had post dose assessments. | Posted | Mean | Standard Deviation | mmHg | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Blood Pressure - Diastolic | Change from baseline in diastolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | Any participants who received study product and had post dose assessments. | Posted | Mean | Standard Deviation | mmHg | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Pulse Rate | Change from baseline in pulse rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | Any participants who received study product and had post dose assessments. | Posted | Mean | Standard Deviation | beats/minute | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Respiratory Rate | Change from baseline in respiratory rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | Any participants who received study product and had post dose assessments. | Posted | Mean | Standard Deviation | breaths/minute | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Temperature | Change from baseline for temperature was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit. | Any participants who received study product and had post dose assessments. | Posted | Mean | Standard Deviation | Celsius | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for White Blood Cells With Differentials | Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Hematology parameters included white blood cell count, and differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils). | Any participants who received study product and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | cells/microliter | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Hemoglobin | Change from baseline for hemoglobin is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Any participants who received study product and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | g/dL | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Hematocrit | Change from baseline for hematocrit is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Any participants who received study product and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | volume percentage of RBC in blood | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Erythrocytes | Change from baseline for erythrocytes is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Any participants who received study product and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | 10^6 cells/microliter | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Platelets | Change from baseline for platelets is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Any participants who received study product for that dosing period and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | 10^3 platelets/microliter | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included sodium, potassium. chloride and bicarbonate. | Any participants who received study product for that dosing period and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | mmol/L | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included magnesium, glucose (fasting), BUN, creatinine, total bilirubin, direct bilirubin | Any participants who received study product for that dosing period and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | mg/dL | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Total Protein and Albumin | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included total protein and albumin. | Any participants who received study product for that dosing period and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | g/dL | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP) | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included AST, ALT and AP. | Any participants who received study product for that dosing period and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | U/L | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline for Glomerular Filtration Rate (GFR) - Estimated | Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. | Any participants who received study product and had post dose laboratory assessments. | Posted | Mean | Standard Deviation | mL/minute | Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Occurrence of Urinalysis Adverse Events Following Administration of Study Product | Urine for the clinical laboratory test was collected on Day -1, 24 hour post dose and the check in for the following dosing period. The results for glucose dipstick, protein dipstick and occult blood - dipstick were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+. If the dipsticks were 1+ or greater, microscopic evaluations were performed for erythrocytes, leukocytes and bacteria. For microscopic results to be deemed abnormal, the results must be reported 6 or greater per high power field. | Any participants who received study product and had post dose laboratory assessments. | Posted | Count of Participants | Participants | From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit). |
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| Secondary | Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval | Change from baseline in ECG is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up). The following ECG Parameters were analyzed: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex), QRS Duration (Time From the Start of the Q-wave to the End of the S-wave), QT Interval (Interval From Onset of the Q-wave to the End of the T-wave), QTcF Interval (QT Interval Corrected by Fridericia's Formula) and RR Interval (Interval From the Peak of the R Wave of a QRS Complex to the Peak of the R Wave of the Next QRS Complex). | Any participants who received study product and had post dose ECG assessments. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up |
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| Secondary | Changes From Baseline in ECG Measures: Ventricular Rate | Change from baseline in ECG Ventricular Rate is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up). | Any participants who received study product and had post dose ECG assessments. | Posted | Mean | Standard Deviation | beats/minute | Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up |
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Unsolicited adverse events and serious adverse events (SAEs) were collected from study product administration to Day 8 after treatment administration or final visit.
Treatment emergent adverse events were defined as new events post-dose, or worsening of existing conditions post-dose. The adverse events were captured by changes in laboratory values, vital signs, ECGs and unsolicited adverse events immediately post dose to Day 8 post each treatment administration or early termination, whichever came first.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 g of Zoliflodacin | 2 g of zoliflodacin administered orally on Day 1 of each dosing period AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. | 0 | 69 | 0 | 69 | 38 | 69 |
| EG001 | 4 g of Zoliflodacin | 4 g of zoliflodacin administered orally on Day 1 of each dosing period AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. | 0 | 67 | 0 | 67 | 46 | 67 |
| EG002 | Placebo | Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. | 0 | 70 | 0 | 70 | 30 | 70 |
| EG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. | 0 | 71 | 0 | 71 | 34 | 71 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (22.1) | Non-systematic Assessment |
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| BACTERIAL TEST POSITIVE | Investigations | MedDRA (22.1) | Non-systematic Assessment |
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| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| HEART RATE DECREASED | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (22.1) | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (22.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George A. Saviolakis, MD, PhD, Medical Director | DynPort Vaccine Company LLC, a GDIT Company | 1-240-651-8116 | George.Saviolakis@gdit.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2018 | Dec 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599190 | zoliflodacin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Withdrawal by Subject |
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| Protocol Violation |
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| Physician Decision |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 hour post dose |
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| 2 hour post dose |
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| 3 hour post dose |
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| 4 hour post dose |
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| 6 hour post dose |
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| 8 hour post dose |
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| 12 hour post dose |
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| 24 hour post dose |
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Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 0.59 | 1-Sided | 95 | 2.200 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 0.17 | 1-Sided | 95 | 1.795 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.42 | 1-Sided | 95 | 3.044 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.17 | 1-Sided | 95 | 2.792 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 0.45 | 1-Sided | 95 | 2.074 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | -0.83 | 1-Sided | 95 | 0.790 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 0.03 | 1-Sided | 95 | 1.650 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | -0.53 | 1-Sided | 95 | 1.131 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.17 | 1-Sided | 95 | 2.815 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 2.36 | 1-Sided | 95 | 3.997 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 2.18 | 1-Sided | 95 | 3.812 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 2.59 | 1-Sided | 95 | 4.228 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 3.04 | 1-Sided | 95 | 4.674 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.63 | 1-Sided | 95 | 3.259 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | -0.07 | 1-Sided | 95 | 1.566 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.82 | 1-Sided | 95 | 3.459 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
| Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms). | Least-Squares Mean Double Delta Value | 1.72 | 1-Sided | 95 | 3.415 | Non-Inferiority | Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. |
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2 g of zoliflodacin administered orally on Day 1 of each dosing period AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. |
| OG002 | 4 g of Zoliflodacin | 4 g of zoliflodacin administered orally on Day 1 of each dosing period AZD0914: Spiropyrimidinetrione antibacterial drug, powder (zoliflodacin) was reconstituted in 60 mL of water and dosed orally following an overnight fast, after which approximately 60 mL of water was added to the cup and consumed by the subject. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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|
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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|
| OG002 | Placebo | Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period
Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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|
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| Placebo |
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| OG002 | Placebo | Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
|
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| Placebo |
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| OG002 |
| Placebo |
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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|
Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| OG002 | Placebo | Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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| OG002 | Placebo | Placebo for zoliflodacin administered orally on Day 1 of each dosing period Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose. |
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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Placebo for zoliflodacin administered orally on Day 1 of each dosing period
Placebo: Composed of 4g of the same excipients found in zoliflodacin. Powder was reconstituted in 60 mL of water and dosed orally. After the cup containing 60 mL of placebo was taken, approximately 60 mL of water was consumed by the subject to chase the initial dose.
| OG003 | 400 mg of Moxifloxacin | 400 mg of moxifloxacin administered orally on Day 1 of each dosing period Moxifloxacin: Broad-spectrum 8-methoxy fluoroquinolone. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride was administered orally with 120 mL of water. |
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