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AZD9833 ,

Phase 1

ER-positive, HER2-negative Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 21, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05364255A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833PHASE1 COMPLETED 6May 10, 2022Jun 20, 2022Jun 21, 20241 United Kingdom
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Study Endpoints
Primary Endpoints
The cumulative amount of AZD9833 excreted (CumAe)
Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of the total radioactivity by measuring the cumulative amount of AZD9833 excreted

The cumulative amount of AZD9833 excreted, expressed as a percentage of the radioactive dose administered (Cum%Ae)
Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of the total radioactivity, expressed as a percentage, by measuring the cumulative amount of AZD9833 excreted

Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Plasma samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Urine samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Faeces samples collected from pre-dose until 168 hours post-dose
Secondary Endpoints
The amount of total radioactivity eliminated in urine (Ae)
Urine samples collected from pre-dose until 168 hours post-dose
The amount of total radioactivity eliminated in urine expressed as a percentage of the radioactive dose administered (%Ae)
Urine samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD9833 excreted in urine (CumAe)
Urine samples collected from pre-dose until 168 hours post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]AZD9833 (D8532C00005)EXPERIMENTALOral Solution, 75 mg (NMT 0.67 MBq)
Interventions
NameTypeDescription
[14C]AZD9833 Oral Solution, 75 mgDRUGOral Solution, 75 mg (NMT 0.67 MBq) - oral, fasted
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Eligibility Criteria
Age Range50 Years — 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Aged between 50 to 70 years inclusive at the time of signing informed consent * Healthy post-menopausal females, defined as post-menopausal by fulfilling the following criterion: ...

Countries:United Kingdom
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