AZD5423 Single Ascending Dose Study

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963183
• Other study ID #: D2340C00001
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2009
• Last updated: January 13, 2015
• Start date: August 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2014
• 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

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of signed, written and dated informed consent prior to any study specific procedures

• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

• Any clinically significant disease or disorder

• Any clinically significant abnormalities at screening examination

• Use of any prescribed or non-prescribed medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD5423
Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
• Placebo
Solution for nebulisation, inhaled. Each subject will receive a single-dose.

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination		Frequent sampling occasions during study days	Yes
Secondary	Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC)		Frequent sampling occasions during study days	No
Secondary	Add'l pharmacokinetics - Terminal rate constant (?z); terminal half-life (t½?z), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT).		Frequent sampling occasions during study days	No
Secondary	Pharmacodynamics - Plasma cortisol concentrations		Frequent sampling occasions during study days	No

External Links

•   Study Synopsis