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| Name | Class |
|---|---|
| Paratek Pharmaceuticals Inc | INDUSTRY |
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The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omadacycline IV followed by PO | Experimental | Omadacycline 100mg IV, Omadacycline 300 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration. | 3 Days |
| Tmax | To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration. | 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. | 3 days |
| Absolute Bioavailability | To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration. | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adupa P Rao, M.D. | Keck Medicine of USC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39581957 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline IV Followed by PO | Participants received a single 100 mg intravenous dose of omadacycline (Nuzyra) administered over 30 minutes, followed by a 7-day washout period and a single 300 mg oral dose of omadacycline (Nuzyra). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OMC 100 mg IV + PK (72 h) |
| |||||||||||||
| Washout (7 days) |
| |||||||||||||
| OMC 300 mg PO + PK (72 h) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline IV Followed by PO | Omadacycline 100mg IV, Omadacycline 300 mg tablet 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration. | Posted | Mean | Standard Deviation | mg/L | 3 Days |
|
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Adverse event data were collected from the day of IV omadacycline administration through three days after the oral omadacycline dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omadacycline 100 mg IV | Single 100 mg intravenous dose of omadacycline administered over 30 minutes, with pharmacokinetic sampling over 72 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Mild dizziness occurred ~2 days after IV omadacycline; lasted ~20 min and self-resolved. Blood glucose was normal; no CF-related diabetes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Beringer | University of Southern California Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences | 3234421402 | beringer@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2025 | Aug 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000591640 | omadacycline |
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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.
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| 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. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | percent (%) predicted |
|
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| Primary | Tmax | To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration. | Posted | Mean | Standard Deviation | hr | 3 days |
|
|
|
| Primary | AUC | To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration. | Posted | Mean | Standard Deviation | h*mg/L | 3 days |
|
|
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| Primary | Absolute Bioavailability | To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration. | Posted | Mean | Standard Deviation | percent (%) | 6 days |
|
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| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | Omadacycline 300 mg PO | Single 300 mg oral dose of omadacycline administered under fasting conditions following a 7-day washout from the IV dose, with pharmacokinetic sampling over 72 hours. | 0 | 9 | 0 | 9 | 1 | 9 |
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| Vulvovaginal candidiasis | Infections and infestations | Non-systematic Assessment | Vaginal yeast infection occurred ~3 days after IV omadacycline. Treated with Monistat; symptoms resolved within 3 days. Reported later to study team. |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment | Participant tested positive for COVID-19 ~1 day after oral omadacycline. Treated with molnupiravir. |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |