Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses in healthy male Japanese subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD5423; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male Japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after the last dose of investigational product
• Have a body mass index (BMI) between 18 and 27 kg/m2 and weight at least 50 kg and no more than 80 kg
• Be able to inhale from the I-nebⓇ according to given instruction

Exclusion Criteria:

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product
• Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigators
• Any positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) and Syphilis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD5423; Inhalation, suspension
Placebo Comparator: 2	Drug: Placebo; Inhalation, solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the safety and tolerability (AE, blood pressure, pulse, ECG, Body temp, Haematology, Clin Chemistry, Urinalysis, phys exam, lung function) of AZD5423 following administration of single and multiple ascending doses.	10-14 days after last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterise the single and multiple dose pharmacokinetics of AZD5423, and assess the dose proportionality, the time required to reach steady state and the degree of accumulation.	72 hours after last dose
To investigate the pharmacodynamic effects (24-hours plasma cortisol AUC, plasma cortisol pre and post ACTH stimulation, DHEAS, osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses.	10-14 days after last dose

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 14, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics; Japanese; pharmacodynamics; AZD5423
• Other Study ID Numbers: D2340C00003