A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD8683 When Administered in Different Ways
December 18, 2012 updated by: AstraZeneca
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™
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
AZD8683 iv
|
Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Solution to be administered orally Total dose of 950 µg AZD8683
Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
|
|
Experimental: 2
AZD8683 oral
|
Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Solution to be administered orally Total dose of 950 µg AZD8683
Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
|
|
Experimental: 3
AZD8683 inhalation New Dry Powder Inhaler
|
Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Solution to be administered orally Total dose of 950 µg AZD8683
Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
|
|
Experimental: 4
AZD8683 inhalation Turbuhaler™
|
Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
Solution to be administered orally Total dose of 950 µg AZD8683
Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Absolute pulmonary bioavailability of AZD8683 delivered by the new dry powder inhaler in terms of: Fpulmonary
Time Frame: 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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute pulmonary bioavailability of AZD8683 delivered by the Turbuhaler™ in terms of: Fpulmonary
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
Time Frame: Screening to 4 weeks after last dose.
|
No formal statistical tests will be performed.
|
Screening to 4 weeks after last dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Carin Jorup, MD, AstraZeneca R&D, Molndal Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
August 14, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 16, 2012
Study Record Updates
Last Update Posted (Estimate)
December 19, 2012
Last Update Submitted That Met QC Criteria
December 18, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- D1883C00008
- EudraCT number 2012-002901-23
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.