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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01310322
First received: February 17, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Healthy
Asthma
Drug: AZD5423
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)


Estimated Enrollment: 12
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD5423 iv
Drug: AZD5423
solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
Experimental: 2
AZD5423 inhalation, Spira
Drug: AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
Experimental: 3
AZD5423 inhalation I-neb
Drug: AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
Experimental: 4
AZD5423 oral
Drug: AZD5423
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310322

Locations
United Kingdom
Research Unit
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham, Dr Quintiles Drug Research Unit at Guy's Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01310322     History of Changes
Other Study ID Numbers: D2340C00008
Study First Received: February 17, 2011
Last Updated: October 26, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
Healthy male volunteers
mild asthmatics
pharmacokinetics
Bioavailability and AUC
Level of AZD5423 in your blood

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014