AZD8683 Single Ascending Dose Study

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AZD8683; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: B; Placebo	Drug: Placebo; Solution for nebulisation, inhaled
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz)	Frequent sampling occasions during study days, before and up to 48 h after dosing.
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)	Frequent sampling occasions during study days, before and up to 48 h after dosing.
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).	Frequent sampling occasions during study days, before and up to 48 h after dosing.
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.	Frequent sampling occasions during study days, before and up to 48 h after dosing.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (Estimate): September 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 2, 2010
• Last Update Submitted That Met QC Criteria: March 1, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: tolerability; safety; inhalation; healthy
• Other Study ID Numbers: D1883C00001