Phase 1
N=18
Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
Community-acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04160260 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: 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 — 9.93 Hours x nanograms/milliliter (h*ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Omadacycline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
9.93 | — |
| PRIMARY Log Geometric Mean AUC From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Oral Omadacycline on Day 1 |
9.27 | — |
| PRIMARY Geometric Mean AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Oral Omadacycline on Day 1 and Day 2 |
8468.9; 8467.8 | — |
| PRIMARY Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Oral Omadacycline on Day 1 and Day 2 |
721.2; 708.6 | — |
| PRIMARY Median Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Oral Omadacycline on Day 1 and Day 2 |
3.0; 2.1 | — |
| PRIMARY 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 |
8.0; 13.1 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-related TEAE, and Serious Adverse Event (SAE) |
10; 8; 0 | — |
Summary
The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04160260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.