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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310322
• Other study ID #: D2340C00008
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2011
• Last updated: January 13, 2015
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma
• Healthy

Intervention

Drug:
• AZD5423
solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
• AZD5423
nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
• AZD5423
nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
• AZD5423
nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423

Locations

Country	Name	City	State
United Kingdom	Research Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)		Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	No
Primary	Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)		Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	No
Primary	Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)		Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	No
Primary	Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).		Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	No
Secondary	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		Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period	No
Secondary	To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.	To evaluate the safety and tolerability of AZD5423 measured by (Adverse events) (Laboratory variables) (Physical examination) (Electrocardiograms) (blood pressure and pulse) (Spirometry)	From screening to follow-up	Yes

External Links

•   CSR Synopsis