MedDataX Logo

A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways

NCT ID: NCT01666613

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to look at drug levels of AZD8683 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with two different devices), to healthy subjects

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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™

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase I, Healthy volunteers, pharmacokinetics Bioavailability AUC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

AZD8683 iv

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683

2

AZD8683 oral

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Solution to be administered orally Total dose of 950 µg AZD8683

3

AZD8683 inhalation New Dry Powder Inhaler

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683

4

AZD8683 inhalation Turbuhaler™

Group Type EXPERIMENTAL

AZD8683

Intervention Type DRUG

Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD8683

Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683

Intervention Type DRUG

AZD8683

Solution to be administered orally Total dose of 950 µg AZD8683

Intervention Type DRUG

AZD8683

Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683

Intervention Type DRUG

AZD8683

Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the inhaler devices used in the study.

Exclusion Criteria

* History of any clinically significant disease or disorder
* Current smokers
* Any clinically relevant abnormal findings in physical examination or laboratory values.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carin Jorup, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Molndal Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT number 2012-002901-23

Identifier Type: -

Identifier Source: secondary_id

D1883C00008

Identifier Type: -

Identifier Source: org_study_id