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

NCT04160260 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PTK0796-CABPPO-19109
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 13

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.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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

• Log Geometric Mean AUC From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Oral Omadacycline on Day 1

  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.

  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

• Geometric Mean AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Oral Omadacycline on Day 1 and Day 2

  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.

  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

• Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Oral Omadacycline on Day 1 and Day 2

  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.

  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

• Median Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Oral Omadacycline on Day 1 and Day 2

  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.

  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

• 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

  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.

  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

Secondary Outcomes (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

Other Outcomes (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

Study Arms (1)

Omadacycline: Omadacycline Tablets

EXPERIMENTAL

Drug: Omadacycline

Interventions

Omadacycline DRUG

Omadacycline: PO Tablets

Also known as: NUZRYA

Omadacycline: Omadacycline Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paratek Pharmaceuticals Inc: lead

Study Sites (13)

Site 105

Birmingham, Alabama, 35215, United States

Location

Site 102

San Diego, California, 92123, United States

Location

Site 104

San Diego, California, 92123, United States

Location

Site 111

Clearwater, Florida, 33756, United States

Location

Site 116

Clearwater, Florida, 33756, United States

Location

Site 106

Doral, Florida, 33166, United States

Location

Site 108

Miami, Florida, 33155, United States

Location

Site 110

Miami, Florida, 33165, United States

Location

Site 112

West Palm Beach, Florida, 33409, United States

Location

Site 103

Butte, Montana, 59701, United States

Location

Site 114

Las Vegas, Nevada, 89106, United States

Location

Site 101

Sherman, Texas, 75092, United States

Location

Site 109

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

omadacycline

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Paratek Medical Information
• Organization: Paratek Pharmaceuticals, Inc.

medinfo@paratekpharma.com

1-833-727-2835

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 12, 2019
• Study Start: November 28, 2019
• Primary Completion: March 23, 2020
• Study Completion: April 13, 2020
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)