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OpenTrials
Completed

NCT Number: NCT01635985

A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects

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Key information

Conditions

Bioavailability and AUC

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

London, UK, United Kingdom

About this study

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
  • Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry

Exclusion criteria

  • History of any clinically significant disease or disorder
  • Current smokers
  • Any clinically relevant abnormal findings

Treatment and study plan

AZD5423

Drug

solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423

Primary outcomes

  1. Pharmacokinetics of AZD5423 delivered by the new dry powder inhaler in terms of: Fpulmonary

    Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.

Secondary outcomes

  1. Pharmacokinetics of AZD5423 following i.v administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Time frame: Blood samples taken pre-dose and at 5, 10, 25, 30, 35 and 45 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48, 72 and 96 hours post dose.

  2. Pharmacokinetics of AZD5423 following oral administration in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36 and 48 hours post dose.

  3. Pharmacokinetics of AZD5423 following oral inhalation by Spira, I-neb, Turbuhaler and New Dry Powder Inhaler in terms of : AUC, AUC(0-t), Fpo, Finhalation total, Fpulmonary, Foral, Frel, Frel Cmax, Cmax, Cmax(tmax), t½λz, MAT, MRT, Vz and Vss

    Time frame: Blood samples taken pre-dose and at10, 20 and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12,16, 24, 36, 48 and 96 hours post dose.

  4. Safety profile in terms of adverse events, ECG, heart rate, blood pressure, pulse rate, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.

    Time frame: Screening to 28 days post dose.

    No formal statistical tests will be performed.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability When Administered Inhaled Via a New Dry Powder Inhaler, Turbuhaler, Spira Nebulizer and I-neb AAD System

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2012
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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