Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Omadacycline: Omadacycline Tablets
|
Drug: Omadacycline
Omadacycline: PO Tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
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.- PTK0796-CABPPO-19109
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
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. |
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. |
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)
|
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)
|
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
|
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
|
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%
|
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
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 |
medinfo@paratekpharma.com |
- PTK0796-CABPPO-19109