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Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tedizolid PO
Tedizolid IV
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tedizolid PO

Tedizolid IV

Arm Description

Tedizolid phophate 200mg tablet

Tedizolid phophate 200mg IV

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)
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)
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)
Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2015
Last Updated
May 21, 2020
Sponsor
University of Southern California
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02444234
Brief Title
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis
Official Title
Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

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Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

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