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AZD6094 film coated

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Jan 26, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

AZD6094 film coated clinical trials

AZD6094 film coated · 1 trial · 1 indication

Phase 1 1
NCT04675021Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male SubjectsCancer
COMPLETED8 Analytics
PHASE1COMPLETED
Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects
CancerUnlock trial analytics

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 to 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 7 trials

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Frequently asked questions about AZD6094 film coated

What is AZD6094 film coated used for?

AZD6094 film coated is an investigational small molecule being studied in oncology for cancer. It is in Phase 1 clinical development, and the single completed trial enrolled healthy male volunteers rather than patients. It is not an approved medicine, so it is not currently used for routine cancer treatment outside of clinical research.

Who makes AZD6094 film coated?

AZD6094 film coated is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this small molecule oncology candidate.

What phase is AZD6094 film coated in?

AZD6094 film coated is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. Because it remains in early clinical development, it is investigational and has not been approved by the FDA for any indication.

What clinical trial has been conducted with AZD6094 film coated?

One completed Phase 1 study has evaluated AZD6094 film coated: NCT04675021, titled Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects. It enrolled 8 healthy male volunteers aged 30 years and older in the United Kingdom. The study was uncontrolled, non-randomized, and not double blinded.

Is AZD6094 film coated the same as savolitinib?

Yes. AZD6094 film coated is also known as AZD6094 (Savolitinib) film coated tablets 600 mg, so savolitinib is the same compound referenced under the AZD6094 code name. The 600 mg film coated tablet is the specific formulation described.