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Ketoconazole

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

Ketoconazole · 1 trial · 1 indication

Phase 1 1
NCT00707551An Interaction Study of Ketoconazole/Verapamil Versus AZD1305Healthy
COMPLETED27 Analytics
PHASE1COMPLETED
An Interaction Study of Ketoconazole/Verapamil Versus AZD1305
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Study Endpoints

Primary Endpoints

Pharmacokinetic variables
During all dosing visits

Secondary Endpoints

Adverse events, vital signs, ECG, laboratory variables and physical examination
During the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALKetoconazole tablet + AZD1305 Extended Release tablet
2EXPERIMENTALVerapamil Extended Release tablet + AZD1305 Extended Release tablet
3EXPERIMENTALAZD1305 Extended Release tablet

Interventions

NameTypeDescription
KetoconazoleDRUGTablet, administered as repeated doses.
VerapamilDRUGExtended Release tablet, administered as repeated doses.
AZD1305DRUGExtended Release tablet, administered as a single dose.
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A body mass index (BMI=weight/height2) of 19 to 30 kg/m2 Exclusion Criteria: * Potassium outside normal reference values * ECG findings outside normal range

Countries:Germany
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Frequently asked questions about Ketoconazole

What is Ketoconazole?

Ketoconazole is a small molecule drug being developed by AstraZeneca PLC (ticker: AZN). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in a clinical trial to assess its interaction with verapamil and AZD1305.

What is Ketoconazole used for?

Ketoconazole is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial that enrolled 27 male participants in Germany. The trial was designed to investigate the interaction of ketoconazole and verapamil with AZD1305.

Who makes Ketoconazole?

Ketoconazole is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development, with a completed trial involving healthy volunteers.

What phase is Ketoconazole in?

Ketoconazole is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. The single clinical trial for this drug has been completed.

What clinical trials is Ketoconazole in?

Ketoconazole has one completed clinical trial, NCT00707551, titled "An Interaction Study of Ketoconazole/Verapamil Versus AZD1305." This Phase 1 trial enrolled 27 healthy male participants in Germany and was a controlled, randomized study.