NCT02444234

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 4, 2019

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

2.5 years

First QC Date

May 6, 2015

Results QC Date

April 25, 2019

Last Update Submit

May 21, 2020

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Tedizolid PO

EXPERIMENTAL

Tedizolid phophate 200mg tablet

Drug: Tedizolid PO

Tedizolid IV

EXPERIMENTAL

Tedizolid phophate 200mg IV

Drug: Tedizolid IV

Interventions

Tedizolid PODRUG

Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.

Tedizolid PO
Tedizolid IVDRUG

Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.

Tedizolid IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CF based on positive sweat chloride or known CF mutation
  • Age \> 17 years
  • Able to spontaneously expectorate sputum

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Paul M Beringer, Pharm.D.
Organization
University of Southern California
beringer@usc.edu
323-442-1402

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 14, 2015

Study Start

July 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 2, 2020

Results First Posted

June 4, 2019

Record last verified: 2020-05

Locations

US(1)