AZD8683 Single Ascending Dose Study

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00979849

First received: September 17, 2009

Last updated: March 1, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 17, 2009

Last Updated Date

March 1, 2010

Start Date ^ICMJE

October 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00979849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ] [ Designated as safety issue: No ]
Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ] [ Designated as safety issue: No ]
Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR). [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ] [ Designated as safety issue: No ]
Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate. [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AZD8683 Single Ascending Dose Study

Official Title ^ICMJE

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD8683 After Single Ascending Doses in Healthy Male Subjects

Brief Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: AZD8683
Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.
Drug: Placebo
Solution for nebulisation, inhaled

Study Arm (s)

Experimental: A
AZD8683

Intervention: Drug: AZD8683
Placebo Comparator: B
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

January 2010

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures
Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion Criteria:

Any clinically significant disease or disorder
Any clinically significant abnormalities at screening examinations
Use any prescribed or non-prescribed medication

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00979849

Other Study ID Numbers ^ICMJE

D1883C00001

Has Data Monitoring Committee

Not Provided

Responsible Party

AstraZeneca, MSD

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Gurdrun Schwabe	AstraZeneca R&D Lund
Principal Investigator:	Sylvan Hurewitz	AstraZeneca CPU, Philadelphia

Information Provided By

AstraZeneca

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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