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

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: AZD8683

Study type: Interventional

Funder types: Industry

Identifiers

NCT01666613

D1883C00008

EudraCT number 2012-002901-23

Details and patient eligibility

About

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

Full description

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™

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

1

Experimental group

Description:

AZD8683 iv

Treatment:

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

2

Experimental group

Description:

AZD8683 oral

Treatment:

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

3

Experimental group

Description:

AZD8683 inhalation New Dry Powder Inhaler

Treatment:

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

4

Experimental group

Description:

AZD8683 inhalation Turbuhaler™

Treatment:

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683

Drug: AZD8683