AZD8683 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 AZD8683 After Single Ascending Doses in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979849
• Other study ID #: D1883C00001
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: March 1, 2010
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• 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 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion Criteria:

• Any clinically significant disease or disorder

• Any clinically significant abnormalities at screening examinations

• Use 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:
• AZD8683
Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.
• Placebo
Solution for nebulisation, inhaled

Locations

Country	Name	City	State
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)		Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing.	Yes
Secondary	Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (?z), terminal half-life (t½?z)		Frequent sampling occasions during study days, before and up to 48 h after dosing.	No
Secondary	Pharmacokinetics: 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), apparent plasma clearance (CL/F)		Frequent sampling occasions during study days, before and up to 48 h after dosing.	No
Secondary	Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR).		Frequent sampling occasions during study days, before and up to 48 h after dosing.	No
Secondary	Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate.		Frequent sampling occasions during study days, before and up to 48 h after dosing.	No