Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

Sponsor
Paratek Pharmaceuticals Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04160260
Collaborator
(none)
18
13
1
4.5
1.4
0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Multi-Center Study to Measure the Pharmacokinetics of Oral Omadacycline in Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)
Actual Study Start Date :
Nov 28, 2019
Actual Primary Completion Date :
Mar 23, 2020
Actual Study Completion Date :
Apr 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Omadacycline: Omadacycline Tablets

Drug: Omadacycline
Omadacycline: PO Tablets
Other Names:
  • NUZRYA
  • Outcome Measures

    Primary Outcome Measures

    1. Log Geometric Mean Area Under the Concentration Versus Time Curve (AUC) From Time 0 to 48 Hours After Dosing (AUC[0-48]) of Oral Omadacycline on Day 2 [Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5, 14, 14.5, 15, 16, and 24 hours post dose. Day 2: pre-dose; 1, 1.5, 2, 2.5, 3, 4, and 6 hours post dose]

      AUC(0-48) was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated statistical analysis software (SAS) program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this pharmacokinetic (PK) endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis. Data for 100 mg intravenous (IV) omadacycline treatment group which was used for comparison in the statistical analysis were obtained from 6 completed studies: PTK 0796-SDES-0501, PTK 0796-BEQU-0801, PTK 0796 WOIV-0703, CPTK796-A2104, CPTK796-A2201, and PTK 0796-RENL-15102. NCT numbers of these studies were not available.

    2. Log Geometric Mean AUC From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Oral Omadacycline on Day 1 [Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5, 14, 14.5, 15, 16, and 24 hours post dose]

      AUC(0-24) was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Day 1, the participant was excluded from PK Analysis. Data for 100 mg intravenous (IV) omadacycline treatment group which was used for comparison in the statistical analysis were obtained from 6 completed studies: PTK 0796-SDES-0501, PTK 0796-BEQU-0801, PTK 0796 WOIV-0703, CPTK796-A2104, CPTK796-A2201, and PTK 0796-RENL-15102. NCT numbers of these studies were not available.

    3. Geometric Mean AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Oral Omadacycline on Day 1 and Day 2 [Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose]

      AUClast was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.

    4. Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Oral Omadacycline on Day 1 and Day 2 [Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose]

      Cmax was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.

    5. Median Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Oral Omadacycline on Day 1 and Day 2 [Day 1: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, 24 hours post dose; Day 2: Pre-dose, 1, 1.5, 2,2.5, 3, 4, 6 hours post-dose]

      Tmax was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.

    6. Median Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (T1/2) of Oral Omadacycline on Day 1 and Day 2 [Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose]

      T1/2 was calculated using the linear regression of the terminal portion of the natural log-plasma concentration versus time curve. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.

    Secondary Outcome Measures

    1. Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-related TEAE, and Serious Adverse Event (SAE) [From the first dose of study drug up to 37 days]

      AEs were defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose. SAEs were defined as any untoward medical occurrence that, at any dose resulted in: death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention.

    Other Outcome Measures

    1. Number of Participants With Clinical Success, Clinical Failure and Indeterminate Clinical Response at the End of Treatment (EOT) as Determined by Investigator Assessment (IGA) [Up to 37 days]

      The investigator determined whether or not the participant met the criteria of 1 of the following clinical outcomes: Clinical success, clinical failure, and indeterminate. Clinical success: Participant was alive and the infection was sufficiently resolved such that further antibacterial therapy was not needed. Clinical Failure: Participant required alternative antibacterial treatment for community-acquired bacterial pneumonia (CABP) prior to EOT related to either progression or development of new symptoms of CABP or development of infectious complications of CABP (eg, empyema, lung abscess) or participant developed an AE that required discontinuation of study therapy. Indeterminate: the clinical response to test article could not be adequately inferred.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female participants, age 18 or older who have signed the informed consent form

    • Must have a qualifying community-acquired bacterial pneumonia

    • Has disease severity such that oral antibiotics therapy is appropriate

    • Participants must not be pregnant at the time of enrollment

    • Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

    • Must be able to swallow tablets and comply with all of the requirements of the study

    Exclusion Criteria:
    • Has received more than 24 hours of a potentially effective systemic antibacterial therapy within the 72 hours prior to the first dose of test article

    • Known or suspected infection caused by a pathogen that may be resistant to test article

    • Participants who reside in a long-term care or nursing home

    • Evidence of empyema

    • Evidence of significant immunological disease

    • Evidence of liver impairment or disease

    • Evidence of unstable cardiac disease

    • Severe renal disease or requirement for dialysis

    • Evidence of septic shock

    • Has a history of hypersensitivity or allergic reaction to any tetracycline

    • Has received an investigational drug within the past 30 days

    • Participants who are pregnant or nursing

    • Unable or unwilling to comply with the protocol requirements

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 105 Birmingham Alabama United States 35215
    2 Site 102 San Diego California United States 92123
    3 Site 104 San Diego California United States 92123
    4 Site 111 Clearwater Florida United States 33756
    5 Site 116 Clearwater Florida United States 33756
    6 Site 106 Doral Florida United States 33166
    7 Site 108 Miami Florida United States 33155
    8 Site 110 Miami Florida United States 33165
    9 Site 112 West Palm Beach Florida United States 33409
    10 Site 103 Butte Montana United States 59701
    11 Site 114 Las Vegas Nevada United States 89106
    12 Site 101 Sherman Texas United States 75092
    13 Site 109 Madison Wisconsin United States 53717

    Sponsors and Collaborators

    • Paratek Pharmaceuticals Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Paratek Pharmaceuticals Inc
    ClinicalTrials.gov Identifier:
    NCT04160260
    Other Study ID Numbers:
    • PTK0796-CABPPO-19109
    First Posted:
    Nov 12, 2019
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 20 participants were screened. Of these, 2 participants failed screening, and 18 participants were enrolled in the study.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Period Title: Overall Study
    STARTED 18
    COMPLETED 18
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Overall Participants 18
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    60.7
    (11.81)
    Sex: Female, Male (Count of Participants)
    Female
    10
    55.6%
    Male
    8
    44.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    18
    100%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Log Geometric Mean Area Under the Concentration Versus Time Curve (AUC) From Time 0 to 48 Hours After Dosing (AUC[0-48]) of Oral Omadacycline on Day 2
    Description AUC(0-48) was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated statistical analysis software (SAS) program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this pharmacokinetic (PK) endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis. Data for 100 mg intravenous (IV) omadacycline treatment group which was used for comparison in the statistical analysis were obtained from 6 completed studies: PTK 0796-SDES-0501, PTK 0796-BEQU-0801, PTK 0796 WOIV-0703, CPTK796-A2104, CPTK796-A2201, and PTK 0796-RENL-15102. NCT numbers of these studies were not available.
    Time Frame Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5, 14, 14.5, 15, 16, and 24 hours post dose. Day 2: pre-dose; 1, 1.5, 2, 2.5, 3, 4, and 6 hours post dose

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic (PK) Population: All participants who received omadacycline and had at least 1 evaluable PK parameter. Two participants who reported emesis within 4 hours post-dose and 1 participant with only Day 1 PK profile and no sampling on Day 2, were excluded from the analysis in 300 mg omadacycline treatment arm. Two additional participants with unusually low PK concentrations deemed as outliers were excluded from the analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 13
    Geometric Mean (Standard Deviation) [Hours x nanograms/milliliter (h*ng/mL)]
    9.93
    (0.364)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 300 mg PO Omadacycline
    Comments Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).
    Type of Statistical Test Equivalence
    Comments Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Geometric Mean Ratio
    Estimated Value 95.17
    Confidence Interval (2-Sided) 90%
    84.2 to 107.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.
    2. Primary Outcome
    Title Log Geometric Mean AUC From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Oral Omadacycline on Day 1
    Description AUC(0-24) was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Day 1, the participant was excluded from PK Analysis. Data for 100 mg intravenous (IV) omadacycline treatment group which was used for comparison in the statistical analysis were obtained from 6 completed studies: PTK 0796-SDES-0501, PTK 0796-BEQU-0801, PTK 0796 WOIV-0703, CPTK796-A2104, CPTK796-A2201, and PTK 0796-RENL-15102. NCT numbers of these studies were not available.
    Time Frame Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5, 14, 14.5, 15, 16, and 24 hours post dose

    Outcome Measure Data

    Analysis Population Description
    PK population. Two participants who reported emesis within 4 hours post-dose on Day 1 were excluded from the analysis in 300 mg omadacycline treatment arm. Two additional participants with unusually low PK concentrations deemed as outliers were excluded from the analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 14
    Geometric Mean (Standard Deviation) [h*ng/mL]
    9.27
    (0.502)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 300 mg PO Omadacycline
    Comments Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).
    Type of Statistical Test Equivalence
    Comments Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Geometric Mean Ratio
    Estimated Value 100.8
    Confidence Interval (2-Sided) 90%
    88.0 to 115.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.
    3. Primary Outcome
    Title Geometric Mean AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Oral Omadacycline on Day 1 and Day 2
    Description AUClast was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.
    Time Frame Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose

    Outcome Measure Data

    Analysis Population Description
    PK population. Two participants who reported emesis within 4 hours post-dose were excluded from the analysis. Additionally, 1 participant with only Day 1 PK profile and no sampling on Day 2, was excluded from the Day 2 analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 18
    Day 1
    8468.9
    (89.9)
    Day 2
    8467.8
    (69.9)
    4. Primary Outcome
    Title Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Oral Omadacycline on Day 1 and Day 2
    Description Cmax was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.
    Time Frame Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose

    Outcome Measure Data

    Analysis Population Description
    PK population. Two participants who reported emesis within 4 hours post-dose were excluded from the Day 1 analysis. Additionally, 1 participant with only Day 1 PK profile and no sampling on Day 2, was excluded from the Day 2 analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 18
    Day 1
    721.2
    (83.9)
    Day 2
    708.6
    (68.7)
    5. Primary Outcome
    Title Median Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Oral Omadacycline on Day 1 and Day 2
    Description Tmax was calculated using the linear trapezoidal linear interpolation method using WinNonlin validated SAS program. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.
    Time Frame Day 1: Pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, 24 hours post dose; Day 2: Pre-dose, 1, 1.5, 2,2.5, 3, 4, 6 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK population. Two participants who reported emesis within 4 hours post-dose were excluded from the Day 1 analysis. Additionally, 1 participant with only Day 1 PK profile and no sampling on Day 2, was excluded from the Day 2 analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 18
    Day 1
    3.0
    Day 2
    2.1
    6. Primary Outcome
    Title Median Elimination Half-life Associated With the Terminal Slope of the Semilogarithmic Concentration-time Curve (T1/2) of Oral Omadacycline on Day 1 and Day 2
    Description T1/2 was calculated using the linear regression of the terminal portion of the natural log-plasma concentration versus time curve. Participants with plasma concentration data above the limit of quantification were included in the analysis for this PK endpoint. If any participant had an emesis within 4 hours after dosing on Study Days 1 and 2, the participant was excluded from PK Analysis.
    Time Frame Day 1: pre-dose; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 13, 13.5,14, 14.5, 15, 16, and 24 hours post dose; Day 2: pre-dose; 1, 1.5, 2,2.5, 3, 4, and 6 hours post dose

    Outcome Measure Data

    Analysis Population Description
    PK population. Two participants who reported emesis within 4 hours post-dose were excluded from the Day 1 analysis. Additionally, 1 participant with only Day 1 PK profile and no sampling on Day 2, was excluded from the Day 2 analysis.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 15
    Day 1
    8.0
    Day 2
    13.1
    7. Secondary Outcome
    Title Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-related TEAE, and Serious Adverse Event (SAE)
    Description AEs were defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose. SAEs were defined as any untoward medical occurrence that, at any dose resulted in: death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event that may have jeopardized the participant or may have required medical or surgical intervention.
    Time Frame From the first dose of study drug up to 37 days

    Outcome Measure Data

    Analysis Population Description
    Safety Population: all enrolled participants who received at least one dose of omadacycline during the study
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 18
    TEAEs
    10
    55.6%
    Treatment-related TEAEs
    8
    44.4%
    SAEs
    0
    0%
    8. Other Pre-specified Outcome
    Title Number of Participants With Clinical Success, Clinical Failure and Indeterminate Clinical Response at the End of Treatment (EOT) as Determined by Investigator Assessment (IGA)
    Description The investigator determined whether or not the participant met the criteria of 1 of the following clinical outcomes: Clinical success, clinical failure, and indeterminate. Clinical success: Participant was alive and the infection was sufficiently resolved such that further antibacterial therapy was not needed. Clinical Failure: Participant required alternative antibacterial treatment for community-acquired bacterial pneumonia (CABP) prior to EOT related to either progression or development of new symptoms of CABP or development of infectious complications of CABP (eg, empyema, lung abscess) or participant developed an AE that required discontinuation of study therapy. Indeterminate: the clinical response to test article could not be adequately inferred.
    Time Frame Up to 37 days

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat (ITT) Population: All enrolled participants regardless of whether they received the study drug. However, all enrolled participants had received oral omadacycline during this study.
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    Measure Participants 18
    Clinical Success
    18
    100%
    Clinical Failure
    0
    0%
    Indeterminate
    0
    0%

    Adverse Events

    Time Frame From the first dose of study drug up to 37 days
    Adverse Event Reporting Description Treatment-emergent adverse events (TEAEs), defined as any AEs that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article, were reported for the Safety Population (all enrolled participants who received at least one dose of oral omadacycline during the study).
    Arm/Group Title 300 mg PO Omadacycline
    Arm/Group Description Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10.
    All Cause Mortality
    300 mg PO Omadacycline
    Affected / at Risk (%) # Events
    Total 0/18 (0%)
    Serious Adverse Events
    300 mg PO Omadacycline
    Affected / at Risk (%) # Events
    Total 0/18 (0%)
    Other (Not Including Serious) Adverse Events
    300 mg PO Omadacycline
    Affected / at Risk (%) # Events
    Total 10/18 (55.6%)
    Gastrointestinal disorders
    Nausea 6/18 (33.3%) 7
    Vomiting 3/18 (16.7%) 5
    Abdominal pain upper 2/18 (11.1%) 2
    Abdominal pain 1/18 (5.6%) 1
    Infections and infestations
    Bronchitis 1/18 (5.6%) 1
    Influenza 1/18 (5.6%) 1
    Metapneumovirus infection 1/18 (5.6%) 1
    Oral candidiasis 1/18 (5.6%) 1
    Investigations
    Alanine aminotransferase increased 1/18 (5.6%) 1
    Aspartate aminotransferase increased 1/18 (5.6%) 1
    Blood alkaline phosphatase increased 1/18 (5.6%) 1
    Nervous system disorders
    Dizziness 1/18 (5.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 1/18 (5.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the Principal Investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication and require the removal of confidential information.

    Results Point of Contact

    Name/Title Paratek Medical Information
    Organization Paratek Pharmaceuticals, Inc.
    Phone 1-833-727-2835
    Email medinfo@paratekpharma.com
    Responsible Party:
    Paratek Pharmaceuticals Inc
    ClinicalTrials.gov Identifier:
    NCT04160260
    Other Study ID Numbers:
    • PTK0796-CABPPO-19109
    First Posted:
    Nov 12, 2019
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021