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

A Phase 1 Multi-Center Study to Measure the Pharmacokinetics of Oral Omadacycline in Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)

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

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