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

AstraZeneca1 site in 1 country130 target enrollmentOctober 2009

ConditionsHealthy Volunteers

InterventionsAZD8683 Placebo

DrugsAZD8683 Placebo

Overview

Phase: Phase 1
Intervention: AZD8683
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 130
Locations: 1
Primary Endpoint: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

January 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

A

AZD8683

Intervention: AZD8683

B

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

Time Frame: 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.

Secondary Outcomes

Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz)(Frequent sampling occasions during study days, before and up to 48 h after dosing.)
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.)
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.)
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.)