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The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omadacycline | Experimental | Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration. |
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| Moxifloxacin | Active Comparator | Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omadacycline | Drug | IV for injection, oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit | Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death | 72 to 120 hours after the first dose of test article |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit | At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Manley | Paratek Pharmaceuticals Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 210 | Gabrovo | Bulgaria | ||||
| Site 213 |
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A total of 670 participants were enrolled in approximately 75 sites globally.
This is a randomized, double-blind, active comparator-controlled study comparing Omadacycline and Moxifloxacin with participants with Community-Acquired Bacterial Pneumonia (CABP). The randomization was stratified by Pneumonia Outcomes Research Team (PORT) Risk Class (III or IV), and receipt of an allowed antibacterial therapy in the 72 hours prior to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline | Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10. |
| FG001 | Moxifloxacin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2020 | Mar 20, 2025 |
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| Moxifloxacin | Drug | IV solution, oral tablets |
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| 5 to 10 days after the last dose of test article |
| Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit | At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred. | 5 to 10 days after the last dose of test article |
| Lom |
| Bulgaria |
| Site 208 | Pernik | Bulgaria |
| Site 201 | Pleven | Bulgaria |
| Site 206 | Rousse | Bulgaria |
| Site 207 | Sliven | Bulgaria |
| Site 202 | Sofia | Bulgaria |
| Site 204 | Sofia | Bulgaria |
| Site 205 | Sofia | Bulgaria |
| Site 209 | Sofia | Bulgaria |
| Site 212 | Vidin | Bulgaria |
| Site 211 | Vratsa | Bulgaria |
| Site 302 | Split | Croatia |
| Site 301 | Zagreb | Croatia |
| Site 303 | Zagreb | Croatia |
| Site 304 | Zagreb | Croatia |
| Site 401 | Tbilisi | Georgia |
| Site 402 | Tbilisi | Georgia |
| Site 403 | Tbilisi | Georgia |
| Site 404 | Tbilisi | Georgia |
| Site 405 | Tbilisi | Georgia |
| Site 406 | Tbilisi | Georgia |
| Site 407 | Tbilisi | Georgia |
| Site 802 | Balassagyarmat | Hungary |
| Site 801 | Budapest | Hungary |
| Site 803 | Debrecen | Hungary |
| Site 804 | Kistarcsa | Hungary |
| Site 805 | Törökbálint | Hungary |
| Site 901 | Chrzanów | Poland |
| Site 904 | Krakow | Poland |
| Site 902 | Oświęcim | Poland |
| Site 903 | Łęczna | Poland |
| Site 506 | Moscow | Russia |
| Site 510 | Moscow | Russia |
| Site 507 | Saint Petersburg | Russia |
| Site 508 | Saint Petersburg | Russia |
| Site 509 | Saint Petersburg | Russia |
| Site 703 | Belgrade | Serbia |
| Site 704 | Belgrade | Serbia |
| Site 705 | Belgrade | Serbia |
| Site 707 | Belgrade | Serbia |
| Site708 | Belgrade | Serbia |
| Site 706 | Kamenitz | Serbia |
| Site 701 | Kragujevac | Serbia |
| Site 702 | Niš | Serbia |
| Site 606 | Dnipro | Ukraine |
| Site 602 | Kharkiv | Ukraine |
| Site 604 | Kharkiv | Ukraine |
| Site 611 | Kharkiv | Ukraine |
| Site 603 | Kyiv | Ukraine |
| Site 605 | Kyiv | Ukraine |
| Site 607 | Kyiv | Ukraine |
| Site 609 | Kyiv | Ukraine |
| Site 608 | Zaporizhia | Ukraine |
| Site 610 | Zaporizhia | Ukraine |
Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10. |
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Intent-to Treat (ITT) population consisted of all randomized participants regardless of whether or not the participant received test article.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline | Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10. |
| BG001 | Moxifloxacin | Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit | Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death | ITT population | Posted | Number | Percentage of participants | 72 to 120 hours after the first dose of test article |
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| Secondary | Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit | At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred. | ITT Population | Posted | Number | Percentage of participants | 5 to 10 days after the last dose of test article |
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| Secondary | Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit | At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred. | CE-PTE Population consisted of all ITT participants who received test article, have a qualifying Community-Acquired Bacterial Pneumonia (CABP), an assessment of outcome, and meet all other evaluability criteria. | Posted | Number | Percentage of participants | 5 to 10 days after the last dose of test article |
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Adverse events were assessed from the from the first dose of study drug up to the time of the final Follow-up assessment (up to 30 to 37 days after the start of the first infusion of test article)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omadacycline | Participants received Omadacycline 200 milligrams (mg) intravenously (IV) once daily or 100 mg IV twice daily on Day 1 and 100 mg IV on Day 2 and 100 mg IV or 300 mg tablets orally once daily from Day 3 through Day 10. | 6 | 336 | 17 | 336 | 32 | 336 |
| EG001 | Moxifloxacin | Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10. | 6 | 332 | 15 | 332 | 36 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Death | General disorders | MedDRA (27.0) | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA (27.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Pyoderma streptococcal | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
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| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paratek Medical Information | Paratek Pharmaceuticals Inc | 1-833-727-2835 | medinfo@paratekpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2024 | Mar 20, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000591640 | omadacycline |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Indeterminate |
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| OG001 | Moxifloxacin | Participants received Moxifloxacin 400 mg IV on Day 1 and Day 2, and 400 mg IV or as oral tablets from Day 3 through Day 10. |
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