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

Phase 1

Completed

• Conditions: Asthma; Healthy
• Interventions: Drug: AZD5423

• Registration Number: NCT01310322
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	AZD5423	AZD5423 oral
1	AZD5423	AZD5423 iv
2	AZD5423	AZD5423 inhalation, Spira
3	AZD5423	AZD5423 inhalation I-neb

Primary Outcome Measures

Name	Time	Method
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
Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Unit; 🇬🇧 London, United Kingdom