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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.
Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tedizolid PO | Experimental | Tedizolid phophate 200mg tablet |
|
| Tedizolid IV | Experimental | Tedizolid phophate 200mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid PO | Drug | Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | 2 days |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose*F/CL | 2 days |
| Time to Peak Plasma Concentration (Tmax) | Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | 2 days |
| Peak Sputum Concentration | Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. | 2 days |
| Area Under the Sputum Concentration Versus Time Curve (AUC) | AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | 2 days |
| Time to Peak Sputum Concentration (Tmax) | Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
This was a cross-over study where patients with CF received tedizolid 200mg IV or PO once daily for 3 doses followed by a minimum 2 day washout and receipt of the remaining dosage form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tedizolid PO/IV | Tedizolid phophate 200mg tablet with crossover to IV Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a minimum 2-day washout. |
| FG001 | Tedizolid IV/PO | Tedizolid phophate 200mg IV with crossover to PO Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a minimum 2-day washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Days) |
| |||||||||||||
| Washout (2 Day Minimum) |
| |||||||||||||
| Second Intervention (3 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomized to receive either tedizolid oral 200 mg tablet or IV 200 mg once daily for 3 days and crossed over to either IV or PO after a minimum of 2 day washout period |
| 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 | Peak Plasma Concentration (Cmax) | Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | Posted | Mean | Standard Deviation | mg/liter | 2 days |
|
10 days
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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 | Tedizolid PO | Tedizolid phophate 200mg tablet Tedizolid PO/IV: Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | General disorders | Systematic Assessment |
Observed a large interindividual variability in the absorption rate constant. Due to difficulty of producing sputum, sputum samples were sparse. Did not include a control population to directly compare the pharmacokinetics in CF patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul M Beringer, Pharm.D. | University of Southern California | 323-442-1402 | 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 | Jul 26, 2016 | Apr 9, 2019 | 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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| Tedizolid IV | Drug | Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Creatinine Clearance | Mean | Standard Deviation | mL/min |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose*F/CL | Posted | Mean | Standard Deviation | mg*h/mL | 2 days |
|
|
|
| Primary | Time to Peak Plasma Concentration (Tmax) | Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | Posted | Mean | Standard Deviation | hours | 2 days |
|
|
|
| Primary | Peak Sputum Concentration | Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. | One patient could not produce sputum | Posted | Mean | Standard Deviation | mg/liter | 2 days |
|
|
|
| Primary | Area Under the Sputum Concentration Versus Time Curve (AUC) | AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose | One patient could not produce sputum | Posted | Mean | Standard Deviation | mg*h/mL | 2 days |
|
|
|
| Primary | Time to Peak Sputum Concentration (Tmax) | Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations. | One patient could not produce sputum | Posted | Mean | Standard Deviation | hours | 2 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Tedizolid IV | Tedizolid phophate 200mg IV Tedizolid IV/PO: Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout. | 0 | 11 | 0 | 11 | 1 | 11 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |