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AZD6094 film coated

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 26, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04675021Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male SubjectsPHASE1 COMPLETED 8 — — Nov 13, 2020Jan 11, 2021Jan 26, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Absolute Bioavailability (F) of savolitinib
Collection of plasma samples from pre-dose to 72 hours post-dose

Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose

The cumulative amount of AZD6094 (savolitinib) 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 AZD6094 (savolitinib) excreted (CumAe)

The cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)
Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of the total radioactivity by measuring the cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)

Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Plasma samples collected until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Urine samples collected until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Faeces samples collected until 168 hours post-dose
Secondary Endpoints
Number of AE's experienced by subjects
AEs recorded from the time of informed consent until the follow up visit (approx 10 weeks)
Time to maximum concentration (tmax) for AZD6094 (savolitinib) and total radioactivity
Collection of plasma samples from pre-dose to 168 hours post-dose
Maximum observed concentration for AZD6094 and total radioactivity
Collection of plasma samples from pre-dose to 168 hours post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD6094 (Savolitinib) D5084C00010EXPERIMENTALAll volunteers will receive either a single dose or two doses of AZD6094 (Savolitinib) D5084C00010
Interventions
NameTypeDescription
AZD6094 (Savolitinib) film coated tablets 600 mgDRUGAZD6094 (Savolitinib) ilm Coated Tablet 200 mg x 3
[14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL)DRUG14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)
[14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)DRUG14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)
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Eligibility Criteria
Age Range30 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 30 to 65 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture. 3. Body mass index (BMI) of 18.0 ...

Countries:United Kingdom
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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