Linezolid in Healthy Volunteers | NCT03841721

Studies
Linezolid in Healthy Volunteers

NCT03841721

Sponsor

Prince of Songkla University

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Linezolid oral tablet 300 mg/day for 5 day

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Aug 1, 2018Actual

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Feb 13, 2019

First Submission Date that Met QC Criteria

Feb 13, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sutep Jaruratanasirikul, Department of Medicine, Faculty of Medicine, Prince of Songkla University, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Linezolid is the first synthetic antibiotic of oxazolidinone group that can inhibit bacterial protein synthesis. Previous studies have found that linezolid was an effective treatment for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB). In addition, the current dosage recommendation (1,200 mg/day) occasionally resulted in serious adverse events including bone marrow suppression and peripheral neuropathy.

The objective study were determine the pharmacokinetics of oral linezolid 300 mg /day in healthy volunteers. This study conducted in six healthy volunteers. All subject received an oral linezolid 300 mg/day by directly observed treatment (DOT) at the same time each day for 5 days. Blood samples were collected on day 5 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h post dosing. The separated plasma samples were evaluated by ultra-performance liquid chromatography (UPLC). All pharmacokinetic parameters were calculated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
linezolid 300 mg	Experimental		Drug: Linezolid oral tablet 300 mg/day for 5 day

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linezolid oral tablet 300 mg/day for 5 day	Drug	Linezolid oral tablet 300 mg/day for 5 day and blood sample were obtained by direct venipuncture at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hour after drug administration in day 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of linezolid in plasma	Individual concentration of linezolid in plasma	24 hour after the linezolid dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20 - 40
BMI 19 - 24 kg/m2
normal CLcr
normal liver function

Exclusion Criteria:

Subject who pregnant
Subject who have documented hypersensitivity to linezolid

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D000069349	Linezolid

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

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Browse Branches

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