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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04460586
- Acronym / sponsor ID
- HS-20-00513
- Conditions
- Cystic Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Paul BeringerUniversity, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Omadacycline IV followed by PO | Experimental | Drug: Omadacycline Injection [Nuzyra], Drug: Omadacycline Oral Tablet [Nuzyra]Omadacycline 100mg IV, Omadacycline 300 mg tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age >=18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omadacycline Injection [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. | Drug | Omadacycline IV followed by PO |
| Omadacycline 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. | Drug | Omadacycline IV followed by PO |
Primary outcome
Cmax
Time frame: 3 Days
To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Tmax
Time frame: 3 days
To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
AUC
Time frame: 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
Time frame: 6 days
To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39581957Sanders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adupa P Rao, M.D. study director
Keck Medicine of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 3 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.