Trial Outcomes & Findings for Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male and Female Subjects (NCT NCT03613649)
NCT ID: NCT03613649
Last Updated: 2020-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
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
Results posted on
2020-03-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
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First Treatment
STARTED
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6
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First Treatment
Received Treatment
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First Treatment
COMPLETED
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First Treatment
NOT COMPLETED
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0
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0
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Second Treatment
STARTED
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Second Treatment
Received Treatment
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Second Treatment
COMPLETED
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Second Treatment
NOT COMPLETED
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1
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Third Treatment
STARTED
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5
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Third Treatment
Received Treatment
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5
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5
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Third Treatment
COMPLETED
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5
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4
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4
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Third Treatment
NOT COMPLETED
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2
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Fourth Treatment
STARTED
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6
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5
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4
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4
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Fourth Treatment
Received Treatment
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5
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5
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4
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4
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6
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4
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Fourth Treatment
COMPLETED
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5
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5
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3
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6
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4
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4
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Fourth Treatment
NOT COMPLETED
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1
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1
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1
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Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Second Treatment
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Treatment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Treatment
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Fourth Treatment
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Treatment
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male and Female Subjects
Baseline characteristics by cohort
| Measure |
2g Zoliflodacin, 4g Zoliflodacin, Placebo, 400mg Moxifloxacin
n=6 Participants
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.
|
2g Zoliflodacin, Placebo, 400mg Moxifloxacin, 4g Zoliflodacin
n=6 Participants
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..
|
2g Zoliflodacin, 400mg Moxifloxacin, 4g Zoliflodacin, Placebo
n=6 Participants
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.
|
4g Zoliflodacin, 2g Zoliflodacin, 400mg Moxifloxacin, Placebo
n=6 Participants
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.
|
4g Zoliflodacin, 400mg Moxifloxacin, Placebo, 2g Zoliflodacin,
n=6 Participants
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.
|
4g Zoliflodacin, Placebo, 2g Zoliflodacin, 400mg Moxifloxacin
n=6 Participants
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.
|
Placebo, 400mg Moxifloxacin, 2g Zoliflodacin, 4g Zoliflodacin,
n=6 Participants
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.
|
Placebo, 2g Zoliflodacin, 4g Zoliflodacin, 400mg Moxifloxacin
n=6 Participants
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.
|
Placebo, 4g Zoliflodacin, 400mg Moxifloxacin, 2g Zoliflodacin
n=6 Participants
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.
|
400mg Moxifloxacin, Placebo, 4g Zoliflodacin, 2g Zoliflodacin
n=6 Participants
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.
|
400mg Moxifloxacin, 4g Zoliflodacin, 2g Zoliflodacin, Placebo
n=6 Participants
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.
|
400mg Moxifloxacin, 2g Zoliflodacin, Placebo, 4g Zoliflodacin
n=6 Participants
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.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
72 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
30.0 years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
32.5 years
STANDARD_DEVIATION 8.1 • n=10 Participants
|
31.7 years
STANDARD_DEVIATION 9.4 • n=115 Participants
|
34.2 years
STANDARD_DEVIATION 5.5 • n=24 Participants
|
28.7 years
STANDARD_DEVIATION 4.5 • n=42 Participants
|
30.8 years
STANDARD_DEVIATION 8.9 • n=42 Participants
|
31.2 years
STANDARD_DEVIATION 7.1 • n=42 Participants
|
29.0 years
STANDARD_DEVIATION 6.8 • n=42 Participants
|
31.7 years
STANDARD_DEVIATION 6.6 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
62 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
35 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
34 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=24 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
72 participants
n=36 Participants
|
|
BMI
|
23.60 kg/m^2
STANDARD_DEVIATION 3.20 • n=5 Participants
|
23.98 kg/m^2
STANDARD_DEVIATION 2.78 • n=7 Participants
|
24.48 kg/m^2
STANDARD_DEVIATION 2.76 • n=5 Participants
|
24.57 kg/m^2
STANDARD_DEVIATION 3.28 • n=4 Participants
|
26.10 kg/m^2
STANDARD_DEVIATION 2.50 • n=21 Participants
|
25.07 kg/m^2
STANDARD_DEVIATION 3.48 • n=10 Participants
|
26.80 kg/m^2
STANDARD_DEVIATION 1.58 • n=115 Participants
|
25.67 kg/m^2
STANDARD_DEVIATION 2.43 • n=24 Participants
|
23.43 kg/m^2
STANDARD_DEVIATION 3.72 • n=42 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 1.68 • n=42 Participants
|
25.35 kg/m^2
STANDARD_DEVIATION 3.71 • n=42 Participants
|
25.03 kg/m^2
STANDARD_DEVIATION 2.83 • n=42 Participants
|
25.03 kg/m^2
STANDARD_DEVIATION 2.87 • n=36 Participants
|
|
Weight
|
71.38 kiliograms
STANDARD_DEVIATION 11.89 • n=5 Participants
|
68.05 kiliograms
STANDARD_DEVIATION 11.16 • n=7 Participants
|
72.65 kiliograms
STANDARD_DEVIATION 14.07 • n=5 Participants
|
70.05 kiliograms
STANDARD_DEVIATION 14.31 • n=4 Participants
|
80.28 kiliograms
STANDARD_DEVIATION 13.93 • n=21 Participants
|
73.63 kiliograms
STANDARD_DEVIATION 14.97 • n=10 Participants
|
80.63 kiliograms
STANDARD_DEVIATION 7.84 • n=115 Participants
|
75.40 kiliograms
STANDARD_DEVIATION 8.74 • n=24 Participants
|
75.57 kiliograms
STANDARD_DEVIATION 17.40 • n=42 Participants
|
78.88 kiliograms
STANDARD_DEVIATION 10.18 • n=42 Participants
|
77.02 kiliograms
STANDARD_DEVIATION 10.28 • n=42 Participants
|
70.85 kiliograms
STANDARD_DEVIATION 14.62 • n=42 Participants
|
74.53 kiliograms
STANDARD_DEVIATION 12.37 • n=36 Participants
|
PRIMARY outcome
Timeframe: 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 zolifloadacinPopulation: 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.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=68 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=66 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=69 Participants
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
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
0.5 hour post dose
|
-3.2 milliseconds (msec)
Interval -4.12 to -2.21
|
-1.0 milliseconds (msec)
Interval -2.08 to 0.17
|
-2.1 milliseconds (msec)
Interval -2.89 to -1.23
|
—
|
|
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
1 hour post dose
|
-1.9 milliseconds (msec)
Interval -2.81 to -1.04
|
0.1 milliseconds (msec)
Interval -1.03 to 1.18
|
-2.3 milliseconds (msec)
Interval -3.34 to -1.29
|
—
|
|
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
2 hour post dose
|
-2.3 milliseconds (msec)
Interval -3.43 to -1.25
|
0.1 milliseconds (msec)
Interval -1.25 to 1.47
|
-2.2 milliseconds (msec)
Interval -3.3 to -1.19
|
—
|
|
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
3 hour post dose
|
-1.6 milliseconds (msec)
Interval -2.79 to -0.41
|
0.1 milliseconds (msec)
Interval -1.54 to 1.69
|
-2.6 milliseconds (msec)
Interval -3.78 to -1.32
|
—
|
|
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
4 hour post dose
|
-2.4 milliseconds (msec)
Interval -3.83 to -0.89
|
0.1 milliseconds (msec)
Interval -1.14 to 1.35
|
-3.3 milliseconds (msec)
Interval -4.36 to -2.16
|
—
|
|
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
6 hour post dose
|
-2.0 milliseconds (msec)
Interval -3.5 to -0.5
|
-0.7 milliseconds (msec)
Interval -2.37 to 1.07
|
-2.3 milliseconds (msec)
Interval -4.55 to -0.06
|
—
|
|
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
8 hour post dose
|
-5.6 milliseconds (msec)
Interval -7.25 to -3.88
|
-4.7 milliseconds (msec)
Interval -6.08 to -3.26
|
-4.4 milliseconds (msec)
Interval -6.23 to -2.67
|
—
|
|
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
12 hour post dose
|
-2.8 milliseconds (msec)
Interval -4.28 to -1.33
|
-0.4 milliseconds (msec)
Interval -2.07 to 1.24
|
-2.2 milliseconds (msec)
Interval -4.11 to -0.27
|
—
|
|
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
24 hour post dose
|
-2.9 milliseconds (msec)
Interval -4.17 to -1.53
|
-0.3 milliseconds (msec)
Interval -1.49 to 0.93
|
-2.2 milliseconds (msec)
Interval -3.69 to -0.77
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: 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.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=68 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=66 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=69 Participants
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
0.5 hour post dose
|
0.4 beats/minute
Interval -0.5 to 1.24
|
2.2 beats/minute
Interval 1.36 to 2.94
|
0.1 beats/minute
Interval -0.5 to 0.77
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
1 hour post dose
|
1.6 beats/minute
Interval 0.6 to 2.55
|
2.3 beats/minute
Interval 1.55 to 3.0
|
-0.6 beats/minute
Interval -1.2 to 0.07
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
2 hour post dose
|
1.0 beats/minute
Interval 0.29 to 1.8
|
3.6 beats/minute
Interval 2.24 to 5.01
|
0.1 beats/minute
Interval -0.62 to 0.82
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
3 hour post dose
|
2.2 beats/minute
Interval 1.35 to 3.0
|
4.5 beats/minute
Interval 3.05 to 5.95
|
0.7 beats/minute
Interval -0.29 to 1.68
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
4 hour post dose
|
1.6 beats/minute
Interval 0.69 to 2.54
|
3.7 beats/minute
Interval 2.32 to 5.04
|
0.00 beats/minute
Interval -0.85 to 0.94
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
6 hour post dose
|
9.4 beats/minute
Interval 7.95 to 10.79
|
10.0 beats/minute
Interval 8.4 to 11.54
|
7.8 beats/minute
Interval 6.62 to 8.95
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
8 hour post dose
|
8.7 beats/minute
Interval 7.52 to 9.89
|
8.3 beats/minute
Interval 6.86 to 9.84
|
5.8 beats/minute
Interval 4.71 to 6.94
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
12 hour post dose
|
10.6 beats/minute
Interval 9.13 to 12.0
|
10.4 beats/minute
Interval 9.01 to 11.77
|
9.7 beats/minute
Interval 8.37 to 10.96
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin
24 hour post dose
|
2.5 beats/minute
Interval 1.6 to 3.37
|
2.8 beats/minute
Interval 1.66 to 3.85
|
3.4 beats/minute
Interval 2.2 to 4.52
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: 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.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=68 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=66 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=69 Participants
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
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
0.5 hour post dose
|
-0.7 milliseconds (msec)
Interval -1.9 to 0.53
|
-1.1 milliseconds (msec)
Interval -2.01 to -0.24
|
-0.3 milliseconds (msec)
Interval -1.35 to 0.74
|
—
|
|
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
1 hour post dose
|
-0.9 milliseconds (msec)
Interval -2.04 to 0.33
|
-2.3 milliseconds (msec)
Interval -3.31 to -1.35
|
0.2 milliseconds (msec)
Interval -0.7 to 1.02
|
—
|
|
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
2 hour post dose
|
-1.6 milliseconds (msec)
Interval -2.69 to -0.47
|
-1.8 milliseconds (msec)
Interval -3.09 to -0.49
|
-0.2 milliseconds (msec)
Interval -1.11 to 0.77
|
—
|
|
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
3 hour post dose
|
-2.6 milliseconds (msec)
Interval -4.11 to -1.02
|
-2.9 milliseconds (msec)
Interval -4.17 to -1.65
|
-1.1 milliseconds (msec)
Interval -2.24 to -0.02
|
—
|
|
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
4 hour post dose
|
-2.8 milliseconds (msec)
Interval -4.0 to -1.52
|
-3.2 milliseconds (msec)
Interval -4.35 to -1.95
|
-0.6 milliseconds (msec)
Interval -1.68 to 0.52
|
—
|
|
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
6 hour post dose
|
-3.6 milliseconds (msec)
Interval -5.6 to -1.69
|
-3.9 milliseconds (msec)
Interval -5.43 to -2.45
|
-1.8 milliseconds (msec)
Interval -3.39 to -0.24
|
—
|
|
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
8 hour post dose
|
-5.7 milliseconds (msec)
Interval -7.43 to -4.03
|
-5.4 milliseconds (msec)
Interval -6.8 to -4.05
|
-5.3 milliseconds (msec)
Interval -6.81 to -3.74
|
—
|
|
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
12 hour post dose
|
-3.0 milliseconds (msec)
Interval -4.69 to -1.4
|
-3.5 milliseconds (msec)
Interval -4.63 to -2.41
|
-4.3 milliseconds (msec)
Interval -5.78 to -2.83
|
—
|
|
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
24 hour post dose
|
-1.7 milliseconds (msec)
Interval -2.88 to -0.49
|
-0.8 milliseconds (msec)
Interval -2.01 to 0.38
|
-0.7 milliseconds (msec)
Interval -1.83 to 0.35
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: 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.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=68 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=66 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=69 Participants
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
6 hour post dose
|
-127.1 milliseconds (msec)
Interval -144.51 to -109.67
|
-133.0 milliseconds (msec)
Interval -152.59 to -113.5
|
-113.7 milliseconds (msec)
Interval -130.03 to -97.3
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
8 hour post dose
|
-120.2 milliseconds (msec)
Interval -135.53 to -104.88
|
-111.0 milliseconds (msec)
Interval -127.57 to -94.37
|
-87.5 milliseconds (msec)
Interval -102.32 to -72.75
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
12 hour post dose
|
-141.2 milliseconds (msec)
Interval -159.18 to -123.21
|
-139.8 milliseconds (msec)
Interval -155.48 to -124.06
|
-140.5 milliseconds (msec)
Interval -159.15 to -121.78
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
24 hour post dose
|
-37.4 milliseconds (msec)
Interval -49.72 to -25.05
|
-41.2 milliseconds (msec)
Interval -57.11 to -25.25
|
-50.2 milliseconds (msec)
Interval -65.39 to -35.06
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
0.5 hour post dose
|
-5.8 milliseconds (msec)
Interval -18.87 to 7.2
|
-33.5 milliseconds (msec)
Interval -46.7 to -20.39
|
-1.2 milliseconds (msec)
Interval -11.7 to 9.35
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
1 hour post dose
|
-22.6 milliseconds (msec)
Interval -36.3 to -8.81
|
-35.0 milliseconds (msec)
Interval -46.45 to -23.58
|
9.7 milliseconds (msec)
Interval -0.72 to 20.08
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
2 hour post dose
|
-13.8 milliseconds (msec)
Interval -25.3 to -2.32
|
-51.0 milliseconds (msec)
Interval -65.99 to -36.07
|
3.0 milliseconds (msec)
Interval -9.34 to 15.29
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
3 hour post dose
|
-32.0 milliseconds (msec)
Interval -43.54 to -20.52
|
-63.1 milliseconds (msec)
Interval -80.01 to -46.21
|
-10.1 milliseconds (msec)
Interval -24.26 to 4.0
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin
4 hour post dose
|
-23.3 milliseconds (msec)
Interval -35.96 to -10.57
|
-47.6 milliseconds (msec)
Interval -64.48 to -30.73
|
-0.7 milliseconds (msec)
Interval -15.6 to 14.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: 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.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=68 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=66 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=69 Participants
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
0.5 hour post dose
|
-0.3 milliseconds (msec)
Interval -0.6 to 0.07
|
-0.1 milliseconds (msec)
Interval -0.45 to 0.24
|
-0.3 milliseconds (msec)
Interval -0.63 to -0.04
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
1 hour post dose
|
-0.5 milliseconds (msec)
Interval -0.87 to -0.16
|
0.1 milliseconds (msec)
Interval -0.23 to 0.38
|
0.0 milliseconds (msec)
Interval -0.28 to 0.34
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
2 hour post dose
|
-0.6 milliseconds (msec)
Interval -0.91 to -0.25
|
-0.5 milliseconds (msec)
Interval -0.9 to -0.2
|
0.0 milliseconds (msec)
Interval -0.47 to 0.47
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
3 hour post dose
|
-0.4 milliseconds (msec)
Interval -0.7 to -0.08
|
-0.4 milliseconds (msec)
Interval -0.72 to -0.07
|
-0.1 milliseconds (msec)
Interval -0.35 to 0.23
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
4 hour post dose
|
-0.5 milliseconds (msec)
Interval -0.82 to -0.19
|
-0.2 milliseconds (msec)
Interval -0.57 to 0.12
|
-0.1 milliseconds (msec)
Interval -0.5 to 0.21
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
6 hour post dose
|
0.1 milliseconds (msec)
Interval -0.34 to 0.49
|
0.1 milliseconds (msec)
Interval -0.25 to 0.49
|
0.8 milliseconds (msec)
Interval 0.43 to 1.22
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
8 hour post dose
|
-0.7 milliseconds (msec)
Interval -1.03 to -0.28
|
-0.7 milliseconds (msec)
Interval -1.08 to -0.26
|
-0.3 milliseconds (msec)
Interval -0.69 to 0.05
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
12 hour post dose
|
-0.4 milliseconds (msec)
Interval -0.79 to 0.02
|
-0.5 milliseconds (msec)
Interval -0.77 to -0.15
|
-0.3 milliseconds (msec)
Interval -0.66 to 0.14
|
—
|
|
Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin
24 hour post dose
|
-0.5 milliseconds (msec)
Interval -0.89 to -0.12
|
-0.2 milliseconds (msec)
Interval -0.61 to 0.18
|
-0.4 milliseconds (msec)
Interval -0.67 to -0.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 h, 2 h, 3 h, and 4 h post-dosePopulation: Any participants who received a dose of moxifloxacin and placebo and had post dose assessments is counted in the population.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=70 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=69 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
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
1 hour post dose
|
7.9 milliseconds (msec)
Interval 6.81 to 8.99
|
-2.3 milliseconds (msec)
Interval -3.34 to -1.29
|
—
|
—
|
|
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
2 hour post dose
|
8.5 milliseconds (msec)
Interval 7.32 to 9.59
|
-2.2 milliseconds (msec)
Interval -3.3 to -1.19
|
—
|
—
|
|
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
3 hour post dose
|
8.0 milliseconds (msec)
Interval 6.67 to 9.36
|
-2.6 milliseconds (msec)
Interval -3.78 to -1.32
|
—
|
—
|
|
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
4 hour post dose
|
7.2 milliseconds (msec)
Interval 5.93 to 8.53
|
-3.3 milliseconds (msec)
Interval -4.36 to -2.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: Any participants who received study product and had post dose assessments.
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).
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=68 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=66 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
1 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
1 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
0.5 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
0.5 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
1 h post: T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
2 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
2 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
2 h post: T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
3 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
3 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
3 h post:T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
4 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
4 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
4 h post:T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
6 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
6 h post dose: T wave: Abnormal, Flat
|
6 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
6 h post:T wave: Abnormal, Inverted, Asymmetric
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
8 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
8 h post dose: T wave: Abnormal, Flat
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
8 h post:T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
12 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
12 h post dose: T wave: Abnormal, Flat
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
12 h post:T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
24 h post dose: T wave: Abnormal, Biphasic
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
24 h post dose: T wave: Abnormal, Flat
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
24 h post:T wave: Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin
0.5 h post: T wave:Abnormal, Inverted, Asymmetric
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseCmax 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Zoliflodacin
|
12120 ng/mL
Standard Deviation 2985
|
20350 ng/mL
Standard Deviation 8682
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseTmax 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Zoliflodacin
|
2.90 hour
Standard Deviation 1.08
|
3.03 hour
Standard Deviation 2.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseAUC(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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0 - Infinity)) for Zoliflodacin
|
108300 h x ng/mL
Standard Deviation 32980
|
181400 h x ng/mL
Standard Deviation 52890
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseAUC(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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin
|
102700 h*ng/mL
Standard Deviation 28580
|
177300 h*ng/mL
Standard Deviation 52370
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseApparent 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=50 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=42 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Zoliflodacin
|
160.55 Liter
Standard Deviation 50.46
|
204.29 Liter
Standard Deviation 55.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseApparent 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=50 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=42 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Zoliflodacin
|
20.08 Liter/hour
Standard Deviation 5.74
|
23.77 Liter/hour
Standard Deviation 6.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseThe 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=50 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=42 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Elimination Rate Constant (Ke) of Zoliflodacin
|
0.1267 1/hour
Standard Deviation 0.01590
|
0.1174 1/hour
Standard Deviation 0.01467
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-doseThe 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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=50 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=42 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Zoliflodacin
|
5.55 Hour
Standard Deviation 0.67
|
5.99 Hour
Standard Deviation 0.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dosePopulation: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=67 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=65 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
Placebo was administered orally on Day 1 of dosing period.
|
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.
|
|---|---|---|---|---|
|
Relationship Between Plasma Concentrations of Zoliflodacin and Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin
|
1.5 milliseconds (msec)
Interval to 2.54
The NA values shown in the lower bounds are a stand-in for negative infinity (-8).
|
3.0 milliseconds (msec)
Interval to 4.41
The NA values shown in the lower bounds are a stand-in for negative infinity (-8).
|
—
|
—
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events Following Administration of Zoliflodacin and Moxifloxacin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product.
Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Following Administration of Study Product
|
38 Participants
|
46 Participants
|
35 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Blood Pressure - Systolic
1 hour post dose
|
0.8 mmHg
Standard Deviation 7.3
|
1.3 mmHg
Standard Deviation 7.9
|
0.8 mmHg
Standard Deviation 7.6
|
0.4 mmHg
Standard Deviation 7.8
|
|
Changes From Baseline for Blood Pressure - Systolic
2 hour post dose
|
0.4 mmHg
Standard Deviation 8.0
|
-0.3 mmHg
Standard Deviation 7.6
|
1.0 mmHg
Standard Deviation 8.6
|
-0.5 mmHg
Standard Deviation 6.8
|
|
Changes From Baseline for Blood Pressure - Systolic
4 hour post dose
|
0.1 mmHg
Standard Deviation 7.1
|
-0.9 mmHg
Standard Deviation 7.5
|
1.0 mmHg
Standard Deviation 7.6
|
-1.7 mmHg
Standard Deviation 7.7
|
|
Changes From Baseline for Blood Pressure - Systolic
24 hour post dose
|
0.0 mmHg
Standard Deviation 8.2
|
-0.4 mmHg
Standard Deviation 7.8
|
1.1 mmHg
Standard Deviation 7.3
|
0.5 mmHg
Standard Deviation 6.9
|
|
Changes From Baseline for Blood Pressure - Systolic
Follow up
|
3.5 mmHg
Standard Deviation 8.2
|
2.3 mmHg
Standard Deviation 6.9
|
3.7 mmHg
Standard Deviation 9.2
|
5.0 mmHg
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Blood Pressure - Diastolic
1 hour post dose
|
0.3 mmHg
Standard Deviation 5.3
|
0.3 mmHg
Standard Deviation 4.8
|
0.8 mmHg
Standard Deviation 6.1
|
1.5 mmHg
Standard Deviation 5.3
|
|
Changes From Baseline for Blood Pressure - Diastolic
2 hour post dose
|
-0.4 mmHg
Standard Deviation 6.0
|
-0.9 mmHg
Standard Deviation 5.1
|
0.6 mmHg
Standard Deviation 6.7
|
1.2 mmHg
Standard Deviation 5.5
|
|
Changes From Baseline for Blood Pressure - Diastolic
4 hour post dose
|
-0.4 mmHg
Standard Deviation 4.9
|
-2.3 mmHg
Standard Deviation 5.3
|
1.1 mmHg
Standard Deviation 5.7
|
-0.1 mmHg
Standard Deviation 5.5
|
|
Changes From Baseline for Blood Pressure - Diastolic
24 hour post dose
|
0.2 mmHg
Standard Deviation 5.3
|
-0.5 mmHg
Standard Deviation 5.7
|
1.4 mmHg
Standard Deviation 5.4
|
1.1 mmHg
Standard Deviation 5.5
|
|
Changes From Baseline for Blood Pressure - Diastolic
Follow up
|
2.2 mmHg
Standard Deviation 5.3
|
0.5 mmHg
Standard Deviation 5.5
|
2.7 mmHg
Standard Deviation 6.7
|
3.8 mmHg
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Pulse Rate
1 hour post dose
|
5.2 beats/minute
Standard Deviation 8.3
|
5.7 beats/minute
Standard Deviation 7.8
|
2.8 beats/minute
Standard Deviation 8.1
|
6.9 beats/minute
Standard Deviation 6.8
|
|
Changes From Baseline for Pulse Rate
2 hour post dose
|
3.9 beats/minute
Standard Deviation 7.8
|
6.5 beats/minute
Standard Deviation 8.0
|
3.8 beats/minute
Standard Deviation 7.5
|
5.5 beats/minute
Standard Deviation 5.8
|
|
Changes From Baseline for Pulse Rate
4 hour post dose
|
5.4 beats/minute
Standard Deviation 8.5
|
5.8 beats/minute
Standard Deviation 8.3
|
3.0 beats/minute
Standard Deviation 9.6
|
5.2 beats/minute
Standard Deviation 8.2
|
|
Changes From Baseline for Pulse Rate
24 hour post dose
|
4.9 beats/minute
Standard Deviation 7.7
|
5.2 beats/minute
Standard Deviation 7.3
|
5.4 beats/minute
Standard Deviation 8.4
|
6.3 beats/minute
Standard Deviation 8.1
|
|
Changes From Baseline for Pulse Rate
Follow up
|
2.0 beats/minute
Standard Deviation 8.7
|
2.8 beats/minute
Standard Deviation 7.7
|
2.0 beats/minute
Standard Deviation 10.3
|
4.2 beats/minute
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Respiratory Rate
1 hour post dose
|
0.8 breaths/minute
Standard Deviation 3.1
|
1.1 breaths/minute
Standard Deviation 2.9
|
1.0 breaths/minute
Standard Deviation 2.8
|
0.4 breaths/minute
Standard Deviation 3.0
|
|
Changes From Baseline for Respiratory Rate
2 hour post dose
|
0.4 breaths/minute
Standard Deviation 3.2
|
0.7 breaths/minute
Standard Deviation 2.9
|
-0.3 breaths/minute
Standard Deviation 3.0
|
0.0 breaths/minute
Standard Deviation 3.0
|
|
Changes From Baseline for Respiratory Rate
4 hour post dose
|
0.8 breaths/minute
Standard Deviation 3.6
|
1.3 breaths/minute
Standard Deviation 3.3
|
-0.2 breaths/minute
Standard Deviation 2.7
|
0.1 breaths/minute
Standard Deviation 3.1
|
|
Changes From Baseline for Respiratory Rate
24 hour post dose
|
0.9 breaths/minute
Standard Deviation 3.1
|
1.0 breaths/minute
Standard Deviation 2.9
|
0.6 breaths/minute
Standard Deviation 2.7
|
0.5 breaths/minute
Standard Deviation 3.0
|
|
Changes From Baseline for Respiratory Rate
Follow up
|
0.6 breaths/minute
Standard Deviation 3.1
|
1.3 breaths/minute
Standard Deviation 3.3
|
0.2 breaths/minute
Standard Deviation 3.0
|
0.6 breaths/minute
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Temperature
1 hour post dose
|
0.08 Celsius
Standard Deviation 0.26
|
0.03 Celsius
Standard Deviation 0.25
|
0.03 Celsius
Standard Deviation 0.27
|
0.05 Celsius
Standard Deviation 0.31
|
|
Changes From Baseline for Temperature
2 hour post dose
|
0.10 Celsius
Standard Deviation 0.21
|
0.06 Celsius
Standard Deviation 0.22
|
0.09 Celsius
Standard Deviation 0.24
|
0.11 Celsius
Standard Deviation 0.23
|
|
Changes From Baseline for Temperature
4 hour post dose
|
0.08 Celsius
Standard Deviation 0.23
|
0.05 Celsius
Standard Deviation 0.27
|
0.09 Celsius
Standard Deviation 0.24
|
0.13 Celsius
Standard Deviation 0.26
|
|
Changes From Baseline for Temperature
24 hour post dose
|
0.09 Celsius
Standard Deviation 0.27
|
0.06 Celsius
Standard Deviation 0.27
|
0.04 Celsius
Standard Deviation 0.27
|
0.10 Celsius
Standard Deviation 0.26
|
|
Changes From Baseline for Temperature
Follow up
|
0.05 Celsius
Standard Deviation 0.28
|
-0.02 Celsius
Standard Deviation 0.31
|
0.00 Celsius
Standard Deviation 0.28
|
0.05 Celsius
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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).
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for White Blood Cells With Differentials
Lymphocytes: Follow up
|
-19.6 cells/microliter
Standard Deviation 497.9
|
-74.1 cells/microliter
Standard Deviation 530.5
|
96.9 cells/microliter
Standard Deviation 482.9
|
-33.7 cells/microliter
Standard Deviation 625.8
|
|
Changes From Baseline for White Blood Cells With Differentials
Leukocytes: 24 hour post dose
|
-246.4 cells/microliter
Standard Deviation 1031.5
|
-129.9 cells/microliter
Standard Deviation 1249.6
|
-64.3 cells/microliter
Standard Deviation 1130.2
|
-282.9 cells/microliter
Standard Deviation 1075.4
|
|
Changes From Baseline for White Blood Cells With Differentials
Leukocytes: Follow up
|
-273.5 cells/microliter
Standard Deviation 1253.1
|
140.3 cells/microliter
Standard Deviation 1486.1
|
35.8 cells/microliter
Standard Deviation 1153.9
|
-84.1 cells/microliter
Standard Deviation 1477.6
|
|
Changes From Baseline for White Blood Cells With Differentials
Neutrophils: 24 hour post dose
|
-248.0 cells/microliter
Standard Deviation 667.7
|
-39.6 cells/microliter
Standard Deviation 955.3
|
-54.3 cells/microliter
Standard Deviation 1036.5
|
-351.3 cells/microliter
Standard Deviation 1008.5
|
|
Changes From Baseline for White Blood Cells With Differentials
Neutrophils: Follow up
|
-272.2 cells/microliter
Standard Deviation 945.4
|
220.4 cells/microliter
Standard Deviation 1136.7
|
-36.1 cells/microliter
Standard Deviation 986.4
|
-59.2 cells/microliter
Standard Deviation 1216.6
|
|
Changes From Baseline for White Blood Cells With Differentials
Lymphocytes: 24 hour post dose
|
3.4 cells/microliter
Standard Deviation 583.2
|
-77.9 cells/microliter
Standard Deviation 499.6
|
-1.9 cells/microliter
Standard Deviation 549.7
|
79.4 cells/microliter
Standard Deviation 556.9
|
|
Changes From Baseline for White Blood Cells With Differentials
Monocytes: 24 hour post dose
|
-7.8 cells/microliter
Standard Deviation 118.2
|
-13.9 cells/microliter
Standard Deviation 125.3
|
-10.6 cells/microliter
Standard Deviation 123.7
|
-16.1 cells/microliter
Standard Deviation 114.8
|
|
Changes From Baseline for White Blood Cells With Differentials
Monocytes: Follow up
|
4.6 cells/microliter
Standard Deviation 118.8
|
-7.6 cells/microliter
Standard Deviation 158.7
|
-25.4 cells/microliter
Standard Deviation 141.0
|
5.2 cells/microliter
Standard Deviation 138.9
|
|
Changes From Baseline for White Blood Cells With Differentials
Eosinophils: 24 hour post dose
|
9.4 cells/microliter
Standard Deviation 65.1
|
4.0 cells/microliter
Standard Deviation 71.0
|
6.0 cells/microliter
Standard Deviation 72.8
|
8.2 cells/microliter
Standard Deviation 64.7
|
|
Changes From Baseline for White Blood Cells With Differentials
Eosinophils: Follow up
|
12.9 cells/microliter
Standard Deviation 80.9
|
2.2 cells/microliter
Standard Deviation 83.9
|
0.7 cells/microliter
Standard Deviation 69.7
|
2.3 cells/microliter
Standard Deviation 61.2
|
|
Changes From Baseline for White Blood Cells With Differentials
Basophils: 24 hour post dose
|
-3.4 cells/microliter
Standard Deviation 13.8
|
-2.5 cells/microliter
Standard Deviation 13.3
|
-3.3 cells/microliter
Standard Deviation 13.5
|
-3.1 cells/microliter
Standard Deviation 14.4
|
|
Changes From Baseline for White Blood Cells With Differentials
Basophils: Follow up
|
0.6 cells/microliter
Standard Deviation 15.7
|
-0.5 cells/microliter
Standard Deviation 14.9
|
-0.2 cells/microliter
Standard Deviation 10.7
|
1.4 cells/microliter
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Hemoglobin
Hemoglobin: 24 hour post dose
|
0.15 g/dL
Standard Deviation 0.71
|
0.01 g/dL
Standard Deviation 0.65
|
0.04 g/dL
Standard Deviation 0.67
|
-0.06 g/dL
Standard Deviation 0.68
|
|
Changes From Baseline for Hemoglobin
Hemoglobin: Follow up
|
-0.01 g/dL
Standard Deviation 0.72
|
-0.23 g/dL
Standard Deviation 0.68
|
-0.06 g/dL
Standard Deviation 0.64
|
-0.13 g/dL
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Hematocrit
Hematocrit: 24 hour post dose
|
0.39 volume percentage of RBC in blood
Standard Deviation 2.04
|
-0.10 volume percentage of RBC in blood
Standard Deviation 2.02
|
0.08 volume percentage of RBC in blood
Standard Deviation 2.08
|
-0.26 volume percentage of RBC in blood
Standard Deviation 2.13
|
|
Changes From Baseline for Hematocrit
Hematocrit: Follow up
|
-0.03 volume percentage of RBC in blood
Standard Deviation 2.26
|
-0.69 volume percentage of RBC in blood
Standard Deviation 2.15
|
-0.10 volume percentage of RBC in blood
Standard Deviation 1.90
|
-0.33 volume percentage of RBC in blood
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Erythrocytes
Erythrocytes: 24 hour post dose
|
0.050 10^6 cells/microliter
Standard Deviation 0.243
|
-0.008 10^6 cells/microliter
Standard Deviation 0.228
|
-0.002 10^6 cells/microliter
Standard Deviation 0.233
|
-0.031 10^6 cells/microliter
Standard Deviation 0.253
|
|
Changes From Baseline for Erythrocytes
Erythrocytes: Follow up
|
-0.005 10^6 cells/microliter
Standard Deviation 0.280
|
-0.088 10^6 cells/microliter
Standard Deviation 0.249
|
-0.029 10^6 cells/microliter
Standard Deviation 0.212
|
-0.053 10^6 cells/microliter
Standard Deviation 0.248
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product for that dosing period and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Platelets
Platelets: 24 hour post dose
|
-8.2 10^3 platelets/microliter
Standard Deviation 25.8
|
-10.3 10^3 platelets/microliter
Standard Deviation 26.9
|
-10.5 10^3 platelets/microliter
Standard Deviation 24.4
|
-15.4 10^3 platelets/microliter
Standard Deviation 23.3
|
|
Changes From Baseline for Platelets
Platelets: Follow up
|
1.7 10^3 platelets/microliter
Standard Deviation 27.8
|
2.9 10^3 platelets/microliter
Standard Deviation 30.4
|
6.2 10^3 platelets/microliter
Standard Deviation 30.3
|
-3.8 10^3 platelets/microliter
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product for that dosing period and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Sodium: 24 hour post dose
|
0.2 mmol/L
Standard Deviation 1.9
|
-0.1 mmol/L
Standard Deviation 1.9
|
0.6 mmol/L
Standard Deviation 1.9
|
0.7 mmol/L
Standard Deviation 1.9
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Chloride: 24 hour post dose
|
1.3 mmol/L
Standard Deviation 2.0
|
1.0 mmol/L
Standard Deviation 1.9
|
1.4 mmol/L
Standard Deviation 2.0
|
1.4 mmol/L
Standard Deviation 2.0
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Sodium: Follow up
|
0.1 mmol/L
Standard Deviation 2.3
|
-0.3 mmol/L
Standard Deviation 1.7
|
0.6 mmol/L
Standard Deviation 1.8
|
0.2 mmol/L
Standard Deviation 1.9
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Potassium: 24 hour post dose
|
0.26 mmol/L
Standard Deviation 0.41
|
0.25 mmol/L
Standard Deviation 0.39
|
0.17 mmol/L
Standard Deviation 0.41
|
0.11 mmol/L
Standard Deviation 0.36
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Potassium: Follow up
|
0.01 mmol/L
Standard Deviation 0.33
|
-0.02 mmol/L
Standard Deviation 0.45
|
0.01 mmol/L
Standard Deviation 0.40
|
-0.01 mmol/L
Standard Deviation 0.41
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Chloride: Follow up
|
0.3 mmol/L
Standard Deviation 2.1
|
-0.3 mmol/L
Standard Deviation 2.3
|
0.5 mmol/L
Standard Deviation 1.7
|
0.1 mmol/L
Standard Deviation 2.1
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Bicarbonate: 24 hour post dose
|
0.2 mmol/L
Standard Deviation 2.4
|
0.1 mmol/L
Standard Deviation 1.8
|
0.6 mmol/L
Standard Deviation 1.9
|
0.4 mmol/L
Standard Deviation 2.1
|
|
Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate
Bicarbonate: Follow up
|
-0.2 mmol/L
Standard Deviation 2.2
|
-0.3 mmol/L
Standard Deviation 2.2
|
0.3 mmol/L
Standard Deviation 2.1
|
-0.1 mmol/L
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product for that dosing period and had post dose laboratory assessments.
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
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Glucose (fasting): 24 hour post dose
|
4.6 mg/dL
Standard Deviation 7.8
|
6.4 mg/dL
Standard Deviation 9.7
|
4.2 mg/dL
Standard Deviation 8.3
|
3.2 mg/dL
Standard Deviation 7.4
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Total Bilirubin: Follow up
|
0.01 mg/dL
Standard Deviation 0.21
|
-0.04 mg/dL
Standard Deviation 0.14
|
-0.01 mg/dL
Standard Deviation 0.17
|
-0.02 mg/dL
Standard Deviation 0.16
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Direct Bilirubin: 24 hour post dose
|
0.00 mg/dL
Standard Deviation 0.07
|
0.02 mg/dL
Standard Deviation 0.06
|
0.00 mg/dL
Standard Deviation 0.06
|
-0.01 mg/dL
Standard Deviation 0.05
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Magnesium: 24 hour post dose
|
0.05 mg/dL
Standard Deviation 0.13
|
0.03 mg/dL
Standard Deviation 0.13
|
0.02 mg/dL
Standard Deviation 0.14
|
0.01 mg/dL
Standard Deviation 0.14
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Magnesium: Follow up
|
0.04 mg/dL
Standard Deviation 0.12
|
0.00 mg/dL
Standard Deviation 0.13
|
0.02 mg/dL
Standard Deviation 0.13
|
0.01 mg/dL
Standard Deviation 0.12
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Glucose (fasting): Follow up
|
-1.2 mg/dL
Standard Deviation 8.7
|
1.5 mg/dL
Standard Deviation 9.8
|
-0.6 mg/dL
Standard Deviation 8.9
|
1.0 mg/dL
Standard Deviation 9.5
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
BUN: 24 hour post dose
|
2.1 mg/dL
Standard Deviation 3.2
|
1.6 mg/dL
Standard Deviation 3.0
|
1.4 mg/dL
Standard Deviation 2.9
|
2.5 mg/dL
Standard Deviation 3.4
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
BUN: Follow up
|
0.7 mg/dL
Standard Deviation 3.3
|
0.0 mg/dL
Standard Deviation 2.9
|
0.1 mg/dL
Standard Deviation 3.0
|
-0.2 mg/dL
Standard Deviation 4.0
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Creatinine: 24 hour post dose
|
0.082 mg/dL
Standard Deviation 0.082
|
0.086 mg/dL
Standard Deviation 0.072
|
0.003 mg/dL
Standard Deviation 0.059
|
0.059 mg/dL
Standard Deviation 0.078
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Creatinine: Follow up
|
0.034 mg/dL
Standard Deviation 0.102
|
-0.011 mg/dL
Standard Deviation 0.089
|
0.006 mg/dL
Standard Deviation 0.071
|
-0.007 mg/dL
Standard Deviation 0.087
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Total Bilirubin: 24 hour post dose
|
0.07 mg/dL
Standard Deviation 0.25
|
0.14 mg/dL
Standard Deviation 0.23
|
-0.01 mg/dL
Standard Deviation 0.24
|
-0.04 mg/dL
Standard Deviation 0.20
|
|
Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin
Direct Bilirubin: Follow up
|
-0.01 mg/dL
Standard Deviation 0.06
|
0.00 mg/dL
Standard Deviation 0.05
|
0.01 mg/dL
Standard Deviation 0.06
|
-0.01 mg/dL
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product for that dosing period and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Total Protein and Albumin
Albumin: Follow up
|
0.00 g/dL
Standard Deviation 0.28
|
-0.05 g/dL
Standard Deviation 0.22
|
0.01 g/dL
Standard Deviation 0.23
|
0.02 g/dL
Standard Deviation 0.23
|
|
Changes From Baseline for Total Protein and Albumin
Total Protein: 24 hour post dose
|
-0.42 g/dL
Standard Deviation 0.45
|
-0.42 g/dL
Standard Deviation 0.39
|
-0.45 g/dL
Standard Deviation 0.43
|
-0.45 g/dL
Standard Deviation 0.38
|
|
Changes From Baseline for Total Protein and Albumin
Total Protein: Follow up
|
-0.01 g/dL
Standard Deviation 0.49
|
-0.06 g/dL
Standard Deviation 0.39
|
-0.01 g/dL
Standard Deviation 0.40
|
0.03 g/dL
Standard Deviation 0.41
|
|
Changes From Baseline for Total Protein and Albumin
Albumin: 24 hour post dose
|
-0.28 g/dL
Standard Deviation 0.25
|
-0.30 g/dL
Standard Deviation 0.23
|
-0.30 g/dL
Standard Deviation 0.24
|
-0.32 g/dL
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product for that dosing period and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
ALT: 24 hour post dose
|
-2.2 U/L
Standard Deviation 4.1
|
-1.7 U/L
Standard Deviation 2.7
|
-1.7 U/L
Standard Deviation 4.0
|
-1.4 U/L
Standard Deviation 3.8
|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
AP: 24 hour post dose
|
-5.2 U/L
Standard Deviation 6.3
|
-3.9 U/L
Standard Deviation 4.6
|
-4.1 U/L
Standard Deviation 4.9
|
-4.2 U/L
Standard Deviation 5.8
|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
AST: 24 hour post dose
|
-2.9 U/L
Standard Deviation 3.0
|
-2.7 U/L
Standard Deviation 5.6
|
-2.7 U/L
Standard Deviation 3.5
|
-2.8 U/L
Standard Deviation 4.4
|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
AST: Follow up
|
0.1 U/L
Standard Deviation 5.6
|
0.0 U/L
Standard Deviation 4.0
|
-0.5 U/L
Standard Deviation 3.3
|
0.6 U/L
Standard Deviation 5.9
|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
ALT: Follow up
|
-0.7 U/L
Standard Deviation 6.9
|
1.6 U/L
Standard Deviation 7.5
|
-0.6 U/L
Standard Deviation 4.2
|
0.8 U/L
Standard Deviation 4.3
|
|
Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)
AP: Follow up
|
-1.7 U/L
Standard Deviation 8.1
|
-0.4 U/L
Standard Deviation 7.0
|
-0.7 U/L
Standard Deviation 4.8
|
1.0 U/L
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline for Glomerular Filtration Rate (GFR) - Estimated
GFR: 24 hour post dose
|
-10.4 mL/minute
Standard Deviation 11.1
|
-9.5 mL/minute
Standard Deviation 8.1
|
-0.1 mL/minute
Standard Deviation 8.1
|
-6.2 mL/minute
Standard Deviation 10.3
|
|
Changes From Baseline for Glomerular Filtration Rate (GFR) - Estimated
GFR: Follow up
|
-5.3 mL/minute
Standard Deviation 16.3
|
1.8 mL/minute
Standard Deviation 11.0
|
-0.7 mL/minute
Standard Deviation 8.5
|
1.5 mL/minute
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).Population: Any participants who received study product and had post dose laboratory assessments.
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.
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=70 Participants
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.
|
|---|---|---|---|---|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Glucose dipstick: Follow up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Occult blood dipstick: 24 hour post dose
|
1 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Glucose dipstick: 24 hour post dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Protein dipstick: 24 hour post dose
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Protein dipstick: Follow up
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Occult blood dipstick: Follow up
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Erythrocytes microscopic: 24 hour post dose
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Erythrocytes microscopic: Follow up
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Leukocytes microscopic: 24 hour post dose
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Leukocytes microscopic: Follow up
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Bacteria microscopic: 24 hour post dose
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Occurrence of Urinalysis Adverse Events Following Administration of Study Product
Bacteria microscopic: Follow up
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow upPopulation: Any participants who received study product and had post dose ECG assessments.
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).
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QRS Duration: Follow up
|
-1.4 milliseconds (msec)
Standard Deviation 6.0
|
0.3 milliseconds (msec)
Standard Deviation 6.9
|
-1.1 milliseconds (msec)
Standard Deviation 5.3
|
-0.2 milliseconds (msec)
Standard Deviation 8.6
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QRS Duration: 1 hr post dose
|
-1.8 milliseconds (msec)
Standard Deviation 4.1
|
-0.6 milliseconds (msec)
Standard Deviation 5.1
|
0.4 milliseconds (msec)
Standard Deviation 5.1
|
-0.5 milliseconds (msec)
Standard Deviation 6.7
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QT Interval: 1 hr post dose
|
-3.6 milliseconds (msec)
Standard Deviation 13.1
|
-6.2 milliseconds (msec)
Standard Deviation 12.2
|
-2.5 milliseconds (msec)
Standard Deviation 11.1
|
-1.4 milliseconds (msec)
Standard Deviation 12.6
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QT Interval: 4 hr post dose
|
-5.0 milliseconds (msec)
Standard Deviation 13.8
|
-9.1 milliseconds (msec)
Standard Deviation 18.3
|
-3.8 milliseconds (msec)
Standard Deviation 14.3
|
2.0 milliseconds (msec)
Standard Deviation 16.1
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QT Interval: Follow up
|
-7.1 milliseconds (msec)
Standard Deviation 20.7
|
-6.6 milliseconds (msec)
Standard Deviation 21.1
|
-8.3 milliseconds (msec)
Standard Deviation 20.2
|
-10.0 milliseconds (msec)
Standard Deviation 18.4
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QTcF Interval: 1 hr post dose
|
1.5 milliseconds (msec)
Standard Deviation 10.8
|
0.6 milliseconds (msec)
Standard Deviation 9.3
|
-0.4 milliseconds (msec)
Standard Deviation 9.2
|
9.2 milliseconds (msec)
Standard Deviation 10.9
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
RR Interval: Follow up
|
-39.6 milliseconds (msec)
Standard Deviation 112.7
|
-45.6 milliseconds (msec)
Standard Deviation 108.6
|
-32.4 milliseconds (msec)
Standard Deviation 125.5
|
-62.1 milliseconds (msec)
Standard Deviation 103.1
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval: 1 hr post dose
|
1.2 milliseconds (msec)
Standard Deviation 8.9
|
0.0 milliseconds (msec)
Standard Deviation 7.7
|
1.3 milliseconds (msec)
Standard Deviation 8.5
|
1.3 milliseconds (msec)
Standard Deviation 11.7
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval: 2 hr post dose
|
1.2 milliseconds (msec)
Standard Deviation 8.3
|
-0.7 milliseconds (msec)
Standard Deviation 7.8
|
0.6 milliseconds (msec)
Standard Deviation 7.6
|
0.4 milliseconds (msec)
Standard Deviation 11.5
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval: 4 hr post dose
|
-0.3 milliseconds (msec)
Standard Deviation 8.0
|
-1.4 milliseconds (msec)
Standard Deviation 8.3
|
-0.4 milliseconds (msec)
Standard Deviation 7.8
|
-0.9 milliseconds (msec)
Standard Deviation 11.6
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval: 24 hr post dose
|
1.1 milliseconds (msec)
Standard Deviation 7.8
|
0.7 milliseconds (msec)
Standard Deviation 7.9
|
0.5 milliseconds (msec)
Standard Deviation 8.2
|
2.8 milliseconds (msec)
Standard Deviation 11.3
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
PR Interval: Follow up
|
-1.2 milliseconds (msec)
Standard Deviation 8.8
|
-1.9 milliseconds (msec)
Standard Deviation 9.8
|
-3.1 milliseconds (msec)
Standard Deviation 9.9
|
-0.9 milliseconds (msec)
Standard Deviation 13.3
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QRS Duration: 2 hr post dose
|
-1.9 milliseconds (msec)
Standard Deviation 6.6
|
-1.4 milliseconds (msec)
Standard Deviation 4.9
|
-0.7 milliseconds (msec)
Standard Deviation 5.9
|
-1.5 milliseconds (msec)
Standard Deviation 8.0
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QRS Duration: 4 hr post dose
|
-2.0 milliseconds (msec)
Standard Deviation 3.9
|
-1.0 milliseconds (msec)
Standard Deviation 5.2
|
-0.7 milliseconds (msec)
Standard Deviation 5.1
|
-1.6 milliseconds (msec)
Standard Deviation 7.4
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QRS Duration: 24 hr post dose
|
-2.7 milliseconds (msec)
Standard Deviation 4.9
|
-1.1 milliseconds (msec)
Standard Deviation 6.8
|
-0.9 milliseconds (msec)
Standard Deviation 5.0
|
-1.1 milliseconds (msec)
Standard Deviation 7.0
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QT Interval: 2 hr post dose
|
-5.3 milliseconds (msec)
Standard Deviation 14.6
|
-7.6 milliseconds (msec)
Standard Deviation 15.6
|
-3.6 milliseconds (msec)
Standard Deviation 13.3
|
2.3 milliseconds (msec)
Standard Deviation 16.7
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QT Interval: 24 hr post dose
|
-6.8 milliseconds (msec)
Standard Deviation 12.3
|
-7.6 milliseconds (msec)
Standard Deviation 15.9
|
-9.9 milliseconds (msec)
Standard Deviation 15.1
|
-3.7 milliseconds (msec)
Standard Deviation 14.1
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QTcF Interval: 2 hr post dose
|
0.4 milliseconds (msec)
Standard Deviation 9.9
|
2.0 milliseconds (msec)
Standard Deviation 10.2
|
-2.9 milliseconds (msec)
Standard Deviation 9.5
|
10.6 milliseconds (msec)
Standard Deviation 11.5
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QTcF Interval: 4 hr post dose
|
0.7 milliseconds (msec)
Standard Deviation 10.8
|
-1.3 milliseconds (msec)
Standard Deviation 12.2
|
-3.0 milliseconds (msec)
Standard Deviation 9.9
|
8.5 milliseconds (msec)
Standard Deviation 12.0
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QTcF Interval: 24 hr post dose
|
1.5 milliseconds (msec)
Standard Deviation 8.5
|
1.9 milliseconds (msec)
Standard Deviation 9.3
|
-3.5 milliseconds (msec)
Standard Deviation 10.3
|
4.1 milliseconds (msec)
Standard Deviation 11.6
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
QTcF Interval: Follow up
|
-1.4 milliseconds (msec)
Standard Deviation 12.7
|
-0.2 milliseconds (msec)
Standard Deviation 12.8
|
-3.8 milliseconds (msec)
Standard Deviation 14.4
|
-1.4 milliseconds (msec)
Standard Deviation 14.9
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
RR Interval: 1 hr post dose
|
-34.9 milliseconds (msec)
Standard Deviation 99.9
|
-48.4 milliseconds (msec)
Standard Deviation 86.0
|
-14.1 milliseconds (msec)
Standard Deviation 80.6
|
-74.5 milliseconds (msec)
Standard Deviation 100.2
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
RR Interval: 2 hr post dose
|
-38.5 milliseconds (msec)
Standard Deviation 99.7
|
-68.7 milliseconds (msec)
Standard Deviation 82.0
|
-3.3 milliseconds (msec)
Standard Deviation 94.0
|
-59.0 milliseconds (msec)
Standard Deviation 107.3
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
RR Interval: 4 hr post dose
|
-38.8 milliseconds (msec)
Standard Deviation 94.7
|
-54.3 milliseconds (msec)
Standard Deviation 102.3
|
-4.8 milliseconds (msec)
Standard Deviation 113.1
|
-46.6 milliseconds (msec)
Standard Deviation 114.0
|
|
Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval
RR Interval: 24 hr post dose
|
-57.6 milliseconds (msec)
Standard Deviation 83.5
|
-66.9 milliseconds (msec)
Standard Deviation 91.3
|
-45.9 milliseconds (msec)
Standard Deviation 106.1
|
-56.8 milliseconds (msec)
Standard Deviation 87.0
|
SECONDARY outcome
Timeframe: Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow upPopulation: Any participants who received study product and had post dose ECG assessments.
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).
Outcome measures
| Measure |
2 g of Zoliflodacin
n=69 Participants
2 g of zoliflodacin administered orally on Day 1 of dosing period.
|
4 g of Zoliflodacin
n=67 Participants
4 g of zoliflodacin administered orally on Day 1 of dosing period.
|
Placebo
n=70 Participants
Placebo was administered orally on Day 1 of dosing period.
|
400 mg of Moxifloxacin
n=71 Participants
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.
|
|---|---|---|---|---|
|
Changes From Baseline in ECG Measures: Ventricular Rate
Ventricular Rate: 1 hr post dose
|
2.4 beats/minute
Standard Deviation 6.6
|
3.3 beats/minute
Standard Deviation 5.3
|
0.9 beats/minute
Standard Deviation 5.1
|
4.7 beats/minute
Standard Deviation 6.2
|
|
Changes From Baseline in ECG Measures: Ventricular Rate
Ventricular Rate: 2 hr post dose
|
2.9 beats/minute
Standard Deviation 6.8
|
4.6 beats/minute
Standard Deviation 6.2
|
0.4 beats/minute
Standard Deviation 6.5
|
3.6 beats/minute
Standard Deviation 6.8
|
|
Changes From Baseline in ECG Measures: Ventricular Rate
Ventricular Rate: 4 hr post dose
|
2.8 beats/minute
Standard Deviation 6.6
|
4.1 beats/minute
Standard Deviation 7.5
|
0.2 beats/minute
Standard Deviation 7.3
|
2.8 beats/minute
Standard Deviation 7.4
|
|
Changes From Baseline in ECG Measures: Ventricular Rate
Ventricular Rate: 24 hr post dose
|
3.9 beats/minute
Standard Deviation 5.8
|
4.6 beats/minute
Standard Deviation 6.4
|
2.9 beats/minute
Standard Deviation 8.0
|
3.5 beats/minute
Standard Deviation 5.8
|
|
Changes From Baseline in ECG Measures: Ventricular Rate
Ventricular Rate: Follow up
|
2.8 beats/minute
Standard Deviation 8.2
|
3.1 beats/minute
Standard Deviation 7.3
|
1.8 beats/minute
Standard Deviation 8.9
|
3.9 beats/minute
Standard Deviation 7.0
|
Adverse Events
2 g of Zoliflodacin
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
4 g of Zoliflodacin
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
400 mg of Moxifloxacin
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 g of Zoliflodacin
n=69 participants at risk
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.
|
4 g of Zoliflodacin
n=67 participants at risk
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.
|
Placebo
n=70 participants at risk
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.
|
400 mg of Moxifloxacin
n=71 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/69 • 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.
|
6.0%
4/67 • Number of events 4 • 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.
|
0.00%
0/70 • 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.
|
0.00%
0/71 • 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.
|
|
Gastrointestinal disorders
NAUSEA
|
2.9%
2/69 • Number of events 2 • 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.
|
9.0%
6/67 • Number of events 6 • 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.
|
1.4%
1/70 • Number of events 1 • 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.
|
4.2%
3/71 • Number of events 3 • 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.
|
|
Investigations
BACTERIAL TEST POSITIVE
|
2.9%
2/69 • Number of events 2 • 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.
|
6.0%
4/67 • Number of events 4 • 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.
|
7.1%
5/70 • Number of events 5 • 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.
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
7.2%
5/69 • Number of events 8 • 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.
|
4.5%
3/67 • Number of events 4 • 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.
|
2.9%
2/70 • Number of events 2 • 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.
|
21.1%
15/71 • Number of events 15 • 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.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
2.9%
2/69 • Number of events 2 • 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.
|
6.0%
4/67 • Number of events 4 • 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.
|
4.3%
3/70 • Number of events 3 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Investigations
HEART RATE DECREASED
|
18.8%
13/69 • Number of events 14 • 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.
|
14.9%
10/67 • Number of events 12 • 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.
|
18.6%
13/70 • Number of events 16 • 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.
|
15.5%
11/71 • Number of events 16 • 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.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.4%
1/69 • Number of events 1 • 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.
|
6.0%
4/67 • Number of events 4 • 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.
|
2.9%
2/70 • Number of events 2 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Nervous system disorders
DYSGEUSIA
|
8.7%
6/69 • Number of events 6 • 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.
|
7.5%
5/67 • Number of events 5 • 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.
|
2.9%
2/70 • Number of events 2 • 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.
|
0.00%
0/71 • 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.
|
|
Nervous system disorders
HEADACHE
|
10.1%
7/69 • Number of events 7 • 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.
|
17.9%
12/67 • Number of events 13 • 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.
|
2.9%
2/70 • Number of events 2 • 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.
|
1.4%
1/71 • Number of events 1 • 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.
|
Additional Information
George A. Saviolakis, MD, PhD, Medical Director
DynPort Vaccine Company LLC, a GDIT Company
Phone: 1-240-651-8116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60