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AZD6094 film coated

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last 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

Clinical trial landscape

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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Frequently asked questions about AZD6094 film coated

What is AZD6094 film coated used for?

AZD6094 film coated is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy male subjects to assess its bioavailability and metabolism.

Who makes AZD6094 film coated?

AZD6094 film coated is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational oncology drug.

What phase is AZD6094 film coated in?

AZD6094 film coated is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetic properties in early-stage clinical trials.

What clinical trials is AZD6094 film coated in?

AZD6094 film coated has been studied in one clinical trial with the identifier NCT04675021. This was a Phase 1 study titled 'Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects.' The trial was completed and enrolled 8 healthy male participants in the United Kingdom.

Is AZD6094 film coated the same as savolitinib?

Yes, AZD6094 film coated is also known as savolitinib. The clinical trial NCT04675021, which studied AZD6094 film coated, is titled 'Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects,' confirming that the drug is referred to by both names.