Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166698
• Other study ID #: D3020C00001
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2010
• Last updated: November 8, 2011
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• 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 purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

• Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.

• 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, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers
• Safety
• Tolerability

Intervention

Drug:
• AZD9819
Inhaled single doses of suspension via SPIRA nebuliser
• AZD9819
Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days
• Placebo
Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

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 variables, adverse events, blood pressure, pulse, body temp, safety lab)		Frequent safety measurements during the study from screening period to follow-up	Yes
Secondary	Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma		Multiple PK blood samples from pre-dose until 96 hours post last dose	No