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

• Status: Completed
• Trial end date: 2020-04-13
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc

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