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AZD9833 film-coated A Dose 1

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 20, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

AZD9833 film-coated A Dose 1 · 1 trial · 1 indication

Phase 1 1
NCT04546347A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833Healthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833
Healthy Volunteers
NCT0454634732
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Study Endpoints

Primary Endpoints

Relative bioavailability of AZD9833 based on Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Collection of plasma samples from pre-dose to 72 hours post-dose

Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on AUC0-t

Relative bioavailability of AZD9833 based on area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Collection of plasma samples from pre-dose to 72 hours post-dose

Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on AUC0-inf

Relative bioavailability of AZD9833 based on Maximum observed concentration (Cmax)
Collection of plasma samples from pre-dose to 72 hours post-dose

Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on Cmax

Secondary Endpoints

Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD9833 vs [14C]-AZD9833 and total radioactivity
Collection of plasma samples from pre-dose to 72 hours post-dose
Number of adverse events (AE) experienced by subjects
AEs recorded from the time of informed consent until discharge from the study (72 hours post-dose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
14CAZD9833 Infusion NMT 22.8 kBq/5mLEXPERIMENTALDose 1 14CAZD9833 Solution for Infusion
AZD9833 film-coated tablet A Dose 1EXPERIMENTALDose 1 AZD9833 film-coated tablet type A
AZD9833 Oral SolutionEXPERIMENTALDose 1 AZD9833 oral solution
AZD9833 film-coated tablet B Dose 1EXPERIMENTALDose 1 AZD9833 film-coated tablet type B
AZD9833 film-coated tablet A Dose 2EXPERIMENTALDose 2 AZD9833 film-coated tablet type A
AZD9833 film-coated tablet B Dose 2EXPERIMENTALDose 2 AZD9833 film-coated tablet type B

Interventions

NameTypeDescription
[14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL)RADIATIONDose of \[14C\]AZD9833 Solution for Infusion
AZD9833 film-coated tablet A Dose 1DRUGDose 1 AZD9833 film-coated tablet A Dose 1
AZD9833 Oral SolutionDRUGAZD9833 Oral Solution
AZD9833 film-coated tablet B Dose 1DRUGAZD9833 film-coated tablet B Dose 1
AZD9833 film-coated tablet A Dose 2DRUGDose 1 of AZD9833 film-coated tablet A Dose 2
AZD9833 film-coated tablet B Dose 2DRUGDose 1 of film-coated tablet B Dose 2
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Eligibility Criteria

Age Range50 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy post-menopausal females, defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the post menopausal range. Subjects taking prescribed medications are permitted on a case by case basis, as long a...

Countries:United Kingdom
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Frequently asked questions about AZD9833 film-coated A Dose 1

What is AZD9833 film-coated A Dose 1 used for?

AZD9833 film-coated A Dose 1 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its pharmacokinetics, including relative bioavailability, food effect, and absolute bioavailability.

Who makes AZD9833 film-coated A Dose 1?

AZD9833 film-coated A Dose 1 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's pharmacokinetic properties in healthy volunteers.

What phase is AZD9833 film-coated A Dose 1 in?

AZD9833 film-coated A Dose 1 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is AZD9833 film-coated A Dose 1 in?

AZD9833 film-coated A Dose 1 has one completed clinical trial, NCT04546347, titled 'A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833'. This Phase 1 study enrolled 32 healthy female volunteers aged 50 years and older in the United Kingdom.

Is AZD9833 film-coated A Dose 1 the same as AZD9833?

AZD9833 film-coated A Dose 1 is a specific formulation and dose of the drug AZD9833. The clinical trial NCT04546347 evaluates the pharmacokinetics of this formulation, including its relative bioavailability, food effect, and absolute bioavailability, in healthy volunteers.