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A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03404167
Recruitment Status : Completed
First Posted : January 19, 2018
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gonorrhoea
Intervention Drug: AZD0914
Enrollment 8
Recruitment Details The trial was performed at a commercial phase 1 unit. Recruitment opened on February 2, 2018 and all eight participants were consented and screened for meeting eligibility criteria prior to enrollment and dosing on Feb 23, 2018.
Pre-assignment Details This was an open-label, non-randomized single-dose oral treatment of eligible participants followed by follow up to eight days after dosing.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin orally in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All participants are included in the baseline analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
26.0  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  12.5%
White
7
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 8 participants
25.50  (1.59)
1.Primary Outcome
Title Maximum Observed Concentration (Cmax) of Zoliflodacin
Hide Description 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.
Time Frame From Day 1 to Day 4
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Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
20863  (7129)
2.Primary Outcome
Title Time of Maximum Observed Concentration (Tmax) of Zoliflodacin
Hide Description Tmax was 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hour
4  (3)
3.Primary Outcome
Title Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Zoliflodacin
Hide Description AUC(0-8) 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(0-8) and 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: h x ng/mL
226750  (85336)
4.Primary Outcome
Title Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin
Hide Description 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
Hide Arm/Group Description:
4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: h x ng/mL
226500  (85340)
5.Primary Outcome
Title Apparent Volume of Distribution (Vz/F) of Zoliflodacin
Hide Description 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Liter
183.6  (58.8)
6.Primary Outcome
Title Apparent Oral Clearance (CL/F) of Zoliflodacin
Hide Description Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-8) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.
Time Frame Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: L/h
19.9  (7.0)
7.Primary Outcome
Title Elimination Rate Constant (Ke) of Zoliflodacin
Hide Description 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: 1/hour
0.108  (0.011)
8.Primary Outcome
Title Terminal Elimination Half-life (t1/2) of Zoliflodacin
Hide Description 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.
Time Frame From Day 1 to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all eight participants.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hour
6.5  (0.6)
9.Secondary Outcome
Title Changes From Baseline for White Blood Cells With Differentials and Platelets
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the Day 4 hematology measurement. Hematology parameters included white blood cell count, differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils), and platelet count.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: 10^9/L
Leukocytes -0.659  (1.668)
Neutrophils -0.118  (0.950)
Lymphocytes -0.465  (0.689)
Monocytes -0.036  (0.075)
Eosinophils -0.035  (0.096)
Basophils -0.008  (0.019)
Platelets -7.1  (21.9)
10.Secondary Outcome
Title Changes From Baseline Hematocrit
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) hematocrit measurement from the Day 4 hematocrit measurement.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: percentage
1.36  (1.68)
11.Secondary Outcome
Title Changes From Baseline Hemoglobin
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) hemoglobin measurement from the Day 4 hemoglobin measurement.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: g/dL
0.46  (0.66)
12.Secondary Outcome
Title Changes From Baseline Red Blood Cell Count
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) red blood cell count measurement from the Day 4 red blood cell count measurement.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: 10^12/L
0.150  (0.201)
13.Secondary Outcome
Title Changes From Baseline for Albumin and Total Protein
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) albumin or total protein measurement from the Day 4 albumin or total protein measurement.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: g/dL
Albumin 0.02  (0.23)
Total Protein 0.11  (0.29)
14.Secondary Outcome
Title Change From Baseline for Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) AP, ALT, or AST measurement from the Day 4 AP, ALT, or AST measurement.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: U/L
Alkaline Phosphatase -3.1  (7.2)
Alanine Aminotransferase 1.5  (4.3)
Aspartate Aminotransferase -0.8  (2.7)
15.Secondary Outcome
Title Change From Baseline for Blood Urea Nitrogen (BUN), Serum Creatinine, Glucose (Fasting at Least 4h), Magnesium, Total and Direct Bilirubin
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included BUN, creatinine, fasting glucose, magnesium, total bilirubin, and direct bilirubin.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Days -1 and 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
BUN -3.0  (2.1)
Creatinine 0.05  (0.08)
Glucose (fasting) -2.6  (3.2)
Magnesium -0.01  (0.08)
Total Bilirubin 0.03  (0.31)
Direct Bilirubin -0.01  (0.06)
16.Secondary Outcome
Title Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Hide Description Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included sodium, potassium, chloride, and bicarbonate.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had safety labs collected on Day -1 and Day 4
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mmol/L
Sodium -1.1  (1.7)
Potassium -0.24  (0.36)
Chloride -3.6  (0.9)
Bicarbonate 0.5  (1.2)
17.Secondary Outcome
Title Changes From Baseline for Blood Pressure - Systolic
Hide Description Change from baseline in systolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time Frame From Day -1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mmHg
1 Hour 1.1  (3.9)
2 Hour 0  (5.9)
4 Hour -3.9  (6.0)
Day 2 -1.1  (5.6)
Day 3 -3.6  (7.4)
Day 4 0.5  (6.5)
Day 8 2.4  (11.4)
18.Secondary Outcome
Title Changes From Baseline for Blood Pressure - Diastolic
Hide Description Change from baseline in diastolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time Frame From Day -1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mmHg
1 Hour 0.1  (5.5)
2 Hour -5.3  (6.1)
4 Hour -4.5  (6.3)
Day 2 -2.8  (7.5)
Day 3 -4.1  (6.5)
Day 4 0.0  (6.3)
Day 8 -1.0  (10.7)
19.Secondary Outcome
Title Changes From Baseline in Oral Temperature
Hide Description Change from baseline in temperature calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time Frame From Day -1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Degress C
1 Hour -0.04  (0.29)
2 Hour 0.03  (0.17)
4 Hour 0.01  (0.24)
Day 2 -0.06  (0.17)
Day 3 -0.09  (0.16)
Day 4 0.06  (0.21)
Day 8 -0.04  (0.23)
20.Secondary Outcome
Title Changes From Baseline in Pulse Rate
Hide Description Change from baseline in pulse rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time Frame From Day -1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Beats per minute
1 Hour -3.8  (11.7)
2 Hour -0.4  (14.0)
4 Hour -3.5  (12.6)
Day 2 -4.3  (12.8)
Day 3 -1.8  (8.7)
Day 4 -1.9  (13.3)
Day 8 1.9  (14.0)
21.Secondary Outcome
Title Changes From Baseline for Respiratory Rate
Hide Description Change from baseline in respiratory rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.
Time Frame From Day -1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
1 Hour 0.3  (1.7)
2 Hour 1.0  (2.1)
4 Hour 0.8  (2.4)
Day 2 0.8  (1.0)
Day 3 0.5  (0.9)
Day 4 0.5  (1.4)
Day 8 0.5  (1.8)
22.Secondary Outcome
Title Changes From Baseline in ECG: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex)
Hide Description Change from baseline in ECG PR Interval 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 72 h after dosing.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: msec
1 Hour 4.0  (8.6)
2 Hour 2.3  (6.6)
4 Hour 1.5  (7.9)
72 Hour 6.9  (7.7)
23.Secondary Outcome
Title Changes From Baseline in ECG: QRS Duration (Time From the Start of the Q-wave to the End of the S-wave)
Hide Description Change from baseline in ECG QRS Duration 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 72 h after dosing.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: msec
1 Hour -0.3  (3.3)
2 Hour 0.5  (2.7)
4 Hour -0.1  (2.7)
72 Hour 1.0  (3.9)
24.Secondary Outcome
Title Changes From Baseline in ECG: QTcF Interval (QT Interval Corrected by Fridericia’s Formula)
Hide Description Change from baseline in ECG QTcF Interval 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 72 h after dosing.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
Hide Arm/Group Description:
4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: msec
1 Hour 1.8  (13.6)
2 Hour 6.8  (13.2)
4 Hour 4.0  (11.6)
72 Hour -2.6  (11.2)
25.Secondary Outcome
Title Changes From Baseline in ECG: QT Interval (Interval From Onset of the Q-wave to the End of the T-wave)
Hide Description Change from baseline in ECG QT Interval 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 72 h after dosing.
Time Frame From Day -1 through Day 4
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Hide Analysis Population Description
Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: msec
1 Hour -1.1  (13.8)
2 Hour 4.6  (15.6)
4 Hour 3.6  (10.8)
72 Hour -6.3  (8.8)
26.Secondary Outcome
Title Changes From Baseline in ECG: 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)
Hide Description Change from baseline in ECG RR Interval 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 72 h after dosing.
Time Frame From Day -1 through Day 4
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Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: msec
1 Hour -23.3  (120.9)
2 Hour -20.3  (122.3)
4 Hour -7.0  (64.5)
72 Hour -30.1  (77.3)
27.Secondary Outcome
Title Changes From Baseline in ECG: Ventricular Rate
Hide Description Change from baseline in ECG Ventricular Rate 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 72 h after dosing.
Time Frame From Day -1 through Day 4
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Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: beats per minute
1 Hour 1.4  (8.0)
2 Hour 0.9  (6.4)
4 Hour 0.0  (3.6)
72 Hour 1.8  (4.9)
28.Secondary Outcome
Title Changes From Baseline for Occult Blood Via Dipstick
Hide Description Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for occult blood were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time Frame From Day -1 through Day 4
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Any participants who received study product and had urine collected on Day -1 and Day 4.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
0
29.Secondary Outcome
Title Changes From Baseline for Glucose Via Dipstick
Hide Description Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for glucose were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
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Any participants who received study product and had urine collected on Day -1 and Day 4.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
30.Secondary Outcome
Title Changes From Baseline for Protein Via Dipstick
Hide Description Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for protein were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.
Time Frame From Day -1 through Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
Any participants who received study product and had urine collected on Day -1 and Day 4.
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
31.Secondary Outcome
Title Occurrence of Unsolicited Treatment-emergent Adverse Events
Hide Description Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.
Time Frame From study product administration (Day 1) to Day 8
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Any participants who received study product
Arm/Group Title Zoliflodacin
Hide Arm/Group Description:

4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting.

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
32.Secondary Outcome
Title Occurrence of Treatment-emergent Serious Adverse Events
Hide Description 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.
Time Frame From study product administration (Day 1) to Day 8
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Hide Analysis Population Description
Any participants who received study product.
Arm/Group Title Zoliflodacin
Hide Arm/Group Description:

4 g (2 sachets of 2 g) of zoliflodacin administered orally to eight participants in the morning of Day 1 after 8 hours of fasting

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Unsolicited Adverse Events and serious adverse events (SAEs) were collected from study product administration to Day 8.
Adverse Event Reporting Description 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 or early termination whichever came first.
 
Arm/Group Title Zoliflodacin
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4 g (2 sachets of 2 g) of zoliflodacin orally in the morning of Day 1 after 8 hours of fasting, n=8

AZD0914: Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent

All-Cause Mortality
Zoliflodacin
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Zoliflodacin
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoliflodacin
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Gastrointestinal disorders   
DIARRHOEA * 1  1/8 (12.50%)  1
ABDOMINAL PAIN * 1  1/8 (12.50%)  1
Investigations   
ELECTROCARDIOGRAM QT PROLONGED * 1  6/8 (75.00%)  6
HEART RATE DECREASED * 1  4/8 (50.00%)  4
NEUTROPHIL COUNT DECREASED * 1  1/8 (12.50%)  1
WHITE BLOOD CELL COUNT DECREASED * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
DERMATITIS CONTACT * 1  1/8 (12.50%)  1
1
Term from vocabulary, MedDRA (21.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: George A. Saviolakis, MD, PhD, Medical Director
Organization: DynPort Vaccine Company LLC, a GDIT Company
Phone: 1-240-651-8116
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03404167     History of Changes
Other Study ID Numbers: 16-0118
HHSN272201500005I
First Submitted: January 4, 2018
First Posted: January 19, 2018
Results First Submitted: February 21, 2019
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019