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

Paratek

Status and phase

Completed

Phase 1

Conditions

Community-acquired Pneumonia

Treatments

Drug: Omadacycline

Study type

Interventional

Funder types

Industry

Identifiers

PTK0796-CABPPO-19109

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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