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Verinurad prolonged release HPMC

Phase 1

Chronic Kidney Disease | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: May 10, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Verinurad prolonged release HPMC · 1 trial · 1 indication

Phase 1 1
NCT04550234A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and AllopurinolChronic Kidney Disease
COMPLETED25 Analytics
PHASE1COMPLETED
A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol
Chronic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period

The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters

AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period

The AUClast of verinurad, allopurinol and oxypurinol were assessed in fasted condition as PK parameters

Cmax: Maximum Observed Plasma Drug Concentration in Fasted State
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period

The Cmax of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters

Secondary Endpoints

Cmax: Maximum Observed Plasma Drug Concentration
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period
AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period
AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration
Day 1, Day 2, Day 3 and Day 4 of each Treatment Period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment 1EXPERIMENTALSubjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fasted state on Day 1.
Treatment 2EXPERIMENTALSubjects will receive verinurad/allopurinol FDC capsule in fasted state on Day 1.
Treatment 3EXPERIMENTALSubjects will receive verinurad/allopurinol FDC capsule in fed state on Day 1.
Treatment 4EXPERIMENTALSubjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1.
Treatment 5EXPERIMENTALSubjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1.

Interventions

NameTypeDescription
Verinurad prolonged release HPMC capsuleDRUGRandomized subjects will receive oral dose of verinurad HPMC capsule.
Allopurinol TabletDRUGRandomized subjects will receive oral dose of allopurinol tablet.
Verinurad/Allopurinol FDC CapsuleDRUGRandomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.
Verinurad prolonged release gelatin CapsuleDRUGRandomized subjects will receive oral dose of Verinurad gelatin capsule.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture. * Have a body mass index between 18 and 30 kg/m\^2 (...

Countries:Germany
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Frequently asked questions about Verinurad prolonged release HPMC

What is Verinurad prolonged release HPMC used for?

Verinurad prolonged release HPMC is an investigational small molecule being studied for chronic kidney disease. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial involving healthy subjects to assess drug availability of different formulations of verinurad and allopurinol.

Who makes Verinurad prolonged release HPMC?

Verinurad prolonged release HPMC is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this drug candidate for chronic kidney disease, with the drug currently in Phase 1 development.

What phase is Verinurad prolonged release HPMC in?

Verinurad prolonged release HPMC is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which studied drug availability of different formulations of verinurad and allopurinol in healthy subjects.

What clinical trials is Verinurad prolonged release HPMC in?

Verinurad prolonged release HPMC has one completed clinical trial, NCT04550234, titled "A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol." This Phase 1 study enrolled 25 participants in Germany and evaluated the drug in healthy volunteers.

Is Verinurad prolonged release HPMC the same as Verinurad?

Verinurad prolonged release HPMC is a specific formulation of verinurad, using hydroxypropyl methylcellulose (HPMC) as a prolonged release matrix. The clinical trial NCT04550234 assessed four different formulations of verinurad and allopurinol, including this prolonged release version, to compare drug availability.