AZD8683 Single Ascending Dose Study

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD8683; Drug: Placebo

• Registration Number: NCT00979849
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Study Start: 2009-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	AZD8683	AZD8683
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States