A study in healthy subjects to investigate Pharmacokinetics of AZD8683 when administered in different ways

Study identifier:D1883C00008

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase I, Single-centre, Open-label, Partly Randomised, Cross-over Single Dose Study in Healthy Volunteers to Evaluate the Absolute Pulmonary Bioavailability of AZD8683 when Administered Inhaled via a New Dry Powder Inhaler and via Turbuhaler™

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD8683

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Nov 2012

Estimated Primary Completion Date: 01 Mar 2013

Estimated Study Completion Date: 01 Mar 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Dec 2012 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 AZD8683 iv	Drug: AZD8683 Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Experimental: 2 AZD8683 oral	Drug: AZD8683 Solution to be administered orally Total dose of 950 µg AZD8683
Experimental: 3 AZD8683 inhalation New Dry Powder Inhaler	Drug: AZD8683 Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Experimental: 4 AZD8683 inhalation Turbuhaler™	Drug: AZD8683 Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

Quintiles Drug Research Unit Call Centr

0800 634 1132

Investigators

Principal Investigator

Carin Jorup

AstraZeneca R&D, Molndal Sweden