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NCT Number: NCT01310322

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

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.

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Key information

Conditions

Healthy Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Unit

London, SE1 1YR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
  • Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
  • Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
  • Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath

Exclusion criteria

  • History of any clinically significant disease or disorder
  • Any clinically relevant abnormal findings
  • Current smokers
  • Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
  • Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study

Treatment and study plan

AZD5423

Drug

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

Primary outcomes

  1. Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  2. Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  3. Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  4. Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary outcomes

  1. To compare the pharmacokinetics between healthy subjects and asthma patients and estimate the basic pharmacokinetic parameters of AZD5423 by measuring e.g. maximum plasma concentration, Cmax

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

  2. To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.

    Time frame: From screening to follow-up

    To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients With Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 When Administered Intravenously, Orally, Inhaled Via SPIRA Nebuliser or Inhaled Via I-neb® AAD Systems

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 8, 2011
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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