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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04546347A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833PHASE1 COMPLETED 32 — — Sep 17, 2020Jan 7, 2021Jan 20, 20211 United Kingdom
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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 — 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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