Clinical trial NCT01310322: A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Asthma
Keywords: Phase I
Healthy male volunteers
mild asthmatics
pharmacokinetics
Bioavailability and AUC
Level of AZD5423 in your blood
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-08
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of AZD5423 measured by: Absolute bioavailability (F)
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
measure: Pharmacokinetics of AZD5423 measured by: Pulmonary bioavailability (Fpulmonary)
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
measure: Pharmacokinetics of AZD5423 measured by: Oral bioavailability after inhaled treatments (Foral)
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
measure: Pharmacokinetics of AZD5423 measured by: Area under the plasma concentration-time curve from time zero to infinity (AUC).
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Secondary outcomes:
measure: 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
timeFrame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
measure: To evaluate the safety and tolerability of AZD5423 measured by adverse events, laboratory variables, physical examination, electrocardiograms, blood pressure and pulse, and spirometry.
timeFrame: From screening to follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Unit
Study officials:
affiliation: Quintiles Drug Research Unit at Guy's Hospital
name: Darren Wilbraham, Dr
role: PRINCIPAL_INVESTIGATOR
References: