Cystic FibrosisPhase 4NCT04460586
Pharmacokinetics of Omadacycline in Cystic Fibrosis
A Phase 4 study testing Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet [Nuzyra] in people with Cystic Fibrosis, run by Paul Beringer at 1 site in United States.
Trial summary
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet [Nuzyra]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Dec 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age >=18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet [Nuzyra]
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omadacycline Injection [Nuzyra]Drug
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
Omadacycline Oral Tablet [Nuzyra]Drug
Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
| Study group | Role | What they receive |
|---|---|---|
| Omadacycline IV followed by PO | Experimental | Omadacycline 100mg IV, Omadacycline 300 mg tablet Receives: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet [Nuzyra] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Measured: 3 Days
Tmax
To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
Measured: 3 days
AUC
To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration.
Measured: 3 days
Absolute Bioavailability
To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jul 2021
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Beringer
- Sponsor type
- University, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Responsible party
- Sponsor-investigator, Paul Beringer, University of Southern California
- Investigators
- Adupa P Rao, M.D., Study director, Keck Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460586
- Sponsor's protocol ID
- HS-20-00513
- Status last verified
- May 2026
- First submitted
- 1 Jul 2020
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sanders M, Hong E, Chung PS, Rao AP, Beringer P. Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis. Clin Pharmacokinet. 2024 Dec;63(12):1701-1709. doi: 10.1007/s40262-024-01440-w. Epub 2024 Nov 24.
PubMed 39581957