Cystic Fibrosis
Conditions
Brief summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Detailed description
Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential source of lung infection in CF patients. As omadacycline demonstrates antimicrobial activity against a number of pathogens in CF, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with CF in the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with CF.
Interventions
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
DRUGOmadacycline Oral Tablet [Nuzyra]
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
Sponsors
Paul Beringer
Paratek Pharmaceuticals Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 3 Days | To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration. |
| Tmax | 3 days | To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration. |
| AUC | 3 days | To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration. |
| Absolute Bioavailability | 6 days | To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration. |
Countries
United States
Contacts
STUDY_DIRECTORAdupa P Rao, M.D.
Keck Medicine of USC
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.11 years STANDARD_DEVIATION 11.37 |
| Body Mass Index (BMI) | 25.55 kg/m^2 STANDARD_DEVIATION 5.12 |
| Forced expiratory volume in 1 second (FEV1) | 71.3 percent (%) predicted STANDARD_DEVIATION 14.2 |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 2 / 9 | 1 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
None listed