Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT02444234 |
Recruitment Status :
Completed
First Posted : May 14, 2015
Results First Posted : June 4, 2019
Last Update Posted : June 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Tedizolid PO Drug: Tedizolid IV | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | December 31, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Tedizolid PO
Tedizolid phophate 200mg tablet
|
Drug: Tedizolid PO
Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout. |
Experimental: Tedizolid IV
Tedizolid phophate 200mg IV
|
Drug: Tedizolid IV
Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout. |
- Peak Plasma Concentration (Cmax) [ Time Frame: 2 days ]Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
- Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: 2 days ]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
- Time to Peak Plasma Concentration (Tmax) [ Time Frame: 2 days ]Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
- Peak Sputum Concentration [ Time Frame: 2 days ]Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.
- Area Under the Sputum Concentration Versus Time Curve (AUC) [ Time Frame: 2 days ]AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
- Time to Peak Sputum Concentration (Tmax) [ Time Frame: 2 days ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of CF based on positive sweat chloride or known CF mutation
- Age > 17 years
- Able to spontaneously expectorate sputum
Exclusion Criteria:
- Any clinically significant laboratory abnormalities
- Presence of an ongoing acute pulmonary exacerbation
- Pregnancy
- Serious past allergy to linezolid or tedizolid
- No alcohol, nicotine, or caffeine-containing products during the study period

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444234
United States, California | |
University of Southern California | |
Los Angeles, California, United States, 90089 |
Documents provided by Paul Beringer, University of Southern California:
Responsible Party: | Paul Beringer, Associate Professor, University of Southern California |
ClinicalTrials.gov Identifier: | NCT02444234 |
Other Study ID Numbers: |
HS-15-00182 |
First Posted: | May 14, 2015 Key Record Dates |
Results First Posted: | June 4, 2019 |
Last Update Posted: | June 2, 2020 |
Last Verified: | May 2020 |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Tedizolid Oxazolidinones Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |