Phase 4
N=9
Pharmacokinetics of Omadacycline in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04460586 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Cmax — 0.733; 0.595 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omadacycline Injection [Nuzyra] (Drug); Omadacycline Oral Tablet [Nuzyra] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paul Beringer
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
0.733; 0.595 | — |
| PRIMARY Tmax |
NA; 2.333 | — |
| PRIMARY AUC |
9.234; 8.902 | — |
| PRIMARY Absolute Bioavailability |
NA; 34.8 | — |
Summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age >=18 years
Exclusion Criteria
- Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs & symptoms and an acute decline in relative FEV1 of 10% or greater.
- Pregnancy or breastfeeding
- Serious past allergy to a tetracycline antibiotic
- No alcohol, nicotine, or caffeine-containing products during the study period
- Hemoglobin < 8 g/dL
Data sourced from ClinicalTrials.gov (NCT04460586). 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.