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flucloxacillin

Phase 3

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Trials Updated: Sep 29, 2017

flucloxacillin development status

Highest phase Phase 3 run by AbbVie (NCT02814916)
Phase scored for GSKPhase 1
Registered trials 2 across 2 sponsors since Jan 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

flucloxacillin clinical trials

flucloxacillin · 1 trial · 1 indication

Phase 1 1
NCT00358371Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)Infections, Bacterial
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Infections, BacterialUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute (Abs.) bioavailability, max. plasma conc., concentration-time curve (AUC) from 0 hto the last quantifiable conc., AUC from 0 h to infinity), timepoint of max. plasma conc., Halflife of drug elimination during the terminal phase
Up to 60 Days

Secondary Endpoints

Elimination rate constant, total Clearance, Volume of distribution at steady state, Volume of distribution during the terminal phase, residual area
Up to 60 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving flucloxacillin 250 mgEXPERIMENTALSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
Subjects receiving flucloxacillin 500 mgEXPERIMENTALSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose

Interventions

NameTypeDescription
flucloxacillin 250 mgDRUGSubjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose
flucloxacillin 500 mgDRUGSubjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers, * Caucasians, * Body Mass Index (BMI) between 19 and 27 kg/m 2; * physically and mentally healthy as judged by means of a medical and standard lab examination; * non-smokers, * ex-smokers or moderate smoker. Exclusion criteria: * medical history, * vital ...

Countries:Germany
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Frequently asked questions about flucloxacillin

What is flucloxacillin used for?

Flucloxacillin is used for bacterial infections. It is a small molecule antibacterial agent in the infectious disease therapeutic area. GSK plc, which trades under the ticker GSK, is developing it. Clinical work to date has focused on bacterial infection indications rather than viral or fungal conditions.

Who makes flucloxacillin?

Flucloxacillin is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor associated with the clinical development program for this antibacterial small molecule in bacterial infections.

What phase is flucloxacillin in?

Flucloxacillin is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 24 participants and was conducted in Germany. It is an investigational agent in clinical development for bacterial infections.

What clinical trials is flucloxacillin in?

Flucloxacillin has been studied in trial NCT00358371, titled Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg). That Phase 1 trial is completed, enrolled 24 healthy adult volunteers aged 18 years and older, and took place in Germany. It was a randomized, controlled study.

What does flucloxacillin target?

Flucloxacillin is a small molecule antibacterial developed for bacterial infections. It is classified in the infectious disease therapeutic area and was evaluated in a Phase 1 bioavailability study of 250 mg and 500 mg capsules in healthy volunteers. GSK plc, ticker GSK, is the developer.