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Infusion

Phase 1

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jul 25, 2019

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Infusion · 1 trial · 1 indication

Phase 1 1
NCT04002427Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594Asthma
COMPLETED6 Analytics
PHASE1COMPLETED
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

AZD7594 excreted (Ae)
Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of total radioactivity by measuring AZD7594 excreted (Ae)

AZD7594 excreted and expressed as a percentage of the administered dose (Fe)
Urine and faecal samples colected from pre-dose until 168 hours post-dose

Assessment of total radioactivity by measuring AZD7594 excreted and expressed as a percentage of the administered dose (Fe)

Cumulative amount of AZD7594 excreted (CumAe)
Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of total radioactivity by measuring the cumulative amount of AZD7594 excreted (CumAe)

Cumulative amount of AZD7594 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 total radioactivity by measuring AZD7594 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
Collection of plasma samples from pre-dose until 168 hours post-dose

Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Collection of faecal samples from pre-dose until 168 hours post-dose

Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Collection of urine samples from pre-dose until 168 hours post-dose

Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Secondary Endpoints

Determination of routes and rates of elimination of [14C]AZD7594
Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Determination of the chemical structure of the "major" metabolites of [14C]AZD7594
Collection of urine adn faeces samples from pre-dose until 168 hours post-dose
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Collection of plasma samples from pre-dose until 168 hours post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Only one study armEXPERIMENTAL\[14C\]AZD7594 Solution for Infusion 5 µg/mL (1.1 kBq/mL) AZD7594 Inhalation Powder, SD3FL Inhaler

Interventions

NameTypeDescription
Intravenous InfusionDRUG30 µg \[14C\]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 hour infusion.
Inhaled doseDRUGA single inhalation on one occasion.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male or non-pregnant, non-lactating female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. 3. Have a body mass index of 18.5 t...

Countries:United Kingdom
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Frequently asked questions about Infusion

What is Infusion used for in asthma?

Infusion is an investigational small molecule being developed by AstraZeneca for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied to understand its pharmacokinetics and metabolism in the body.

Who makes Infusion?

Infusion is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug for asthma.

What phase is Infusion in?

Infusion is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials. The Phase 1 trial for Infusion has been completed, and the drug remains in early-stage development for asthma.

What clinical trials is Infusion in?

Infusion has one completed Phase 1 clinical trial registered under NCT04002427, titled "Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594." The trial enrolled 6 participants with asthma in the United Kingdom and was an uncontrolled, non-randomized study.

Is Infusion the same as AZD7594?

Yes, Infusion is also known as AZD7594. The clinical trial NCT04002427 for Infusion is titled "Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594," confirming that AZD7594 is the alternative name for this investigational drug being developed by AstraZeneca.