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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: AZD8683

• Registration Number: NCT01666613
• Lead Sponsor: AstraZeneca

Brief Summary

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

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™

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Study Start: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD8683	AZD8683 iv
2	AZD8683	AZD8683 oral
3	AZD8683	AZD8683 inhalation New Dry Powder Inhaler
4	AZD8683	AZD8683 inhalation Turbuhaler™

Primary Outcome Measures

Name	Time	Method
Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary	Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.

Secondary Outcome Measures

Name	Time	Method
Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary	Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post dose.
Pharmacokinetics of AZD8683 following administration in terms of oral inhalation by Turbuhaler™ and New Dry Powder Inhaler in terms of: Finhalation total, FrelAUC, Frel Cmax and Foral	Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72, 96, 120 and 144 hours post dose.
Pharmacokinetics of AZD8683 following oral administration in terms of: Fpo	Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12 ,24, 36, and 48 hours post dose.
Pharmacokinetics of AZD8683 following oral administration and oral inhalation by Turbuhaler™ and New Dry Powder inhaler in terms of : AUC, AUC(0-t), Cmax, tmax, t½λz, MRT and MAT.	Blood samples taken pre-dose and at 5, 15 and 30 minutes and 1, 2, 4, 8, 12,24, 36, 48, 72 96, 120 and 144 hours post dose.
Pharmacokinetics of AZD8683 following i.v. administration in terms of: CL, Vz, and Vss	Blood samples taken pre-dose and at 5, 15, 20, 25 and 40 minutes and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose.
Safety profile in terms of adverse events, ECG, heart rate, blood pressure, body temperature, physical examination, spirometry, haematology, clinical chemistry and urinalysis.	Screening to 4 weeks after last dose.	No formal statistical tests will be performed.