Phase 4
Completed N=9
Pharmacokinetics of Omadacycline in Cystic Fibrosis
Source: ClinicalTrials.gov NCT04460586 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Cmax — 0.733; 0.595 mg/L
◆ Published Evidence
Emerging
2citations · ~1 / year
Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis.
Summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Linked Publications
-
Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.