AZD8683 Single Ascending Dose Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: AZD8683 Drug: Placebo	Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	130
Study Start Date:	October 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A AZD8683	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.
Placebo Comparator: B Placebo	Drug: Placebo Solution for nebulisation, inhaled

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979849

Locations

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	AstraZeneca, MSD
ClinicalTrials.gov Identifier:	NCT00979849 History of Changes
Other Study ID Numbers:	D1883C00001
Study First Received:	September 17, 2009
Last Updated:	March 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

safety
tolerability
healthy
inhalation

ClinicalTrials.gov processed this record on June 13, 2013